> ie 9 = aw 4 = (i F 9 = fe) =| = a a 4 i > a F fe) ° Ww n A LABORATORY MANUAL FOR HOSPITAL AND CLINICAL PHARMACY Maharashtra State Board of Technical Education, Mumbai (Autonomous) (ISO 9001 : 2015) (ISO / IEC 27001 : 2013)ren To ensure that the Diploma level Technical Education constantly matches the latest requirements of technology and industry and includes the all-round personal development of students including social concerns and to become globally competitive, technology led organization, MISSION To provide high quality technical and managerial manpower, information and consultancy services to the industry and community to enable the industry and community to face the changing technological and environmental challenges. nda We, at MSBTE are committed to offer the best in class academic services to the students and institutes to enhance the delight of industry and society. This will be achieved through continual improvement in management practices adopted in the process of curriculum design, development, implementation, evaluation and monitoring system along with adequate faculty development programmes. Cas) MSBTE believes in the following: + Education industry produces live products. + Market requirements do not wait for curriculum changes. * Question paper is the reflector of academic standards of educational organization. + Well designed curriculum needs effective implementation too. + Competency based curriculum is the backbone of need based program. + Technical skills do need support of life skills. + Best teachers are the national assets. + Effective teaching leaming process is impossible without learning resources.A Laboratory Manual for HOSPITAL AND CLINICAL PHARMACY (0816) Second year Diploma in Pharmacy (PH) Maharashtra State Board of Technical Education, Mumbai (Autonomous) (ISO-9001-2015) (ISO/IEC 27001:2013)Maharashtra State Board of Technical Education, (Autonomous) (ISO 9001 :2015 ) (ISO/IEC 27001 : 2013) 4th Floor, Government Polytechnic Building, 49, Kherwadi, Bandra ( East ), Mumbai - 400051 (Printed on June, 2014)MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION Certificate ‘This is to certify that, Mr/Ms./Mrs. Roll No. of Second Year Diploma in Pharmacy of, (institute) has Completed the term ‘work satisfactorily in Hospital and Clinical Pharmacy PR. (0816) for the academic year 200___ to 200___as prescribed in the curriculum. Place Enrollment No. Date Exam. Seat No. ) ( Subject Teacher PrincipalHosptaland Clinical Pharmacy (0818) LEARNING OVERVIEW Hospital Pharmacy Hospital pharmacy is the department (services), in a hospital which is working under the direction of a professionally competent, legally qualified pharmacist The department supplies medications to the nursing units and other services, fils prescriptions to inpatients, ambulatory patients and outpatients. The department also takes care of: 1. Manufacturing of pharmaceuticals in bulk 2. Dispensing of narcotic and other prescribed drugs. 3. Storing and dispensing of biologicals. 4. Preparation of injectables. 5. Stocking and dispensing of professional supplies. Objectives of hospital pharmacy are: 1. To educate the hospital pharmacist about the philosophy and ethics of hospital pharmacy and their personal responsibilty for professional practice, 2. To strengthen and expand the scientific and professional aspect of practice of hospital pharmacy. To strengthen and perfect the administrative or management skils and tools essential to the role as the departmental head. To professionalize the functioning of pharmaceutical services in a hospital hospital pharmacist in ‘To serve as a counselling department to the patient, medical staff and nursing staff. ‘To participate in research projects to improve upon from time to time, To plan, organize and direct pharmacy policies procedures in keeping with the established policies of hospitals, Clinical Pharmacy: Clinical pharmacy is a patient oriented service. It includes the dispensing of required medication and advising the patient on the safe and effective use of all medications. The pharmacist is providing services to the patient and the medical profession through his comprehensive knowledge of pharmacological, pharmacokinetics and biopharmaceutical principles and through application of this knowledge to existing linical situation. He helps in optimization of drug therapy and dosage individualization thus maximizing the benefits derived from therapy and minimizing the risk associated with drug use. Objectives of Clinical Pharmacy are: To render the pharmaceutical care 2. To focus on the pharmacist altitude, behaviour, commitment, concems, ethics, knowledge, responsibilities and skills on the provision of drug therapy with improvement of the patients “quality of life” Itinvolves judgments and decision to avoid, initiate, maintain or discontinue drug therapy. 4. To focus and emphasize on the rational use of drugs by delivering professional knowledge of pharmacy and drug products to patients. To assist the physicians in prescribing and monitoring drug therapy. To help nurses in administering medications and documenting medications in ‘To maximize the patient's role in drug use process. (MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) LINK / BLOCK DIAGRAM SHOWING INTER RELATIONSHIP OF SUBJECT AREAS, CURRICULUM OBJECTIVES AND JOB PROFILE CORE TECHNOLOGY ‘TECHNOLOGY SUBJECT Pharmaceuties- Pharmaceutical Chemistry Pharmacognosy Biochemistry and Clinical Pathology Human Anatomy and Physiology 1, Pharmaceutics- 2. Pharmaceutical Chemistry-t 3. Pharmacology and Toxicology 4, Pharmaceutical Jurisprudence 5. Drug Stores and Business > Management Health Education and Community Pharmacy 6 | Hospital and Clinical Pharmacy 7. Practical Training JOB PROFILE ‘CURRICULUM OBJECTIVES Entrepreneur (wholesaler, Distributor, 4. Develop attude for personal Chemist and Druggist) development Industry 2. Develop social skills for social Skiled personnel (Buk drug development formulations, cosmetics) 3. Develop continued leaming skis for Medical representative life long learning Hospital 4. Gain basic knowledge of human Pharmacist (aispensing, lg | body and various itnesses, Manufacturing) Supervisor ‘Community Pharmacist ‘Academic Institution (Laboratory technician) Repackaging of Drugs other than those specified in Schedule C and C1 of Drugs and Cosmetics Act 1940 ‘and Rules 1945, disorders 5. Understand various drugs, their formulations and counseling to patients for their appropriate use. 6 Develop communication skils. 7. Develop technical skills for industry and hospital activities, MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) GRAPHICAL STRUCTURE OF SUBJECT AREA Second Year Diploma in Pharmacy Hospital and Clinical Pharmacy (0816) Hospital and community pharmacy practice. Applicationsiproblems Educational and Technical services. Research and support services. Minimizing the risk associated with drug use. Pharmaceutical care. Flawless drug distribution system, Plan, organize and direct pharmacy policies, procedures Sterile product division, Unit dose dispensing division, Ambulatory care and Home Procedures care service division. t Medication History, Drug therapy regimen, Dispensing, Counseling the patient,Patient compliance, ‘Therapeutic response (Desirable, Adverse drug reaction, Drug interaction) Professionalize the functioning of Principles pharmaceutical services in t Stronger pharmacist. patient relationship, Closer interactions with physician. ‘Strengthen and expand the scientific and professional Concepts aspects of the practice of pharmacy, to attract a greater number of welktrained pharmacist Safe, effective and rational use of | Department under professionally Facts ‘competent pharmacist Patient oriented Hospital Pharmacy Clinical Pharmacy MARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) DEVELOPMENT OF SKILLS Following is the broad perspective of acquisition of intellectual and motor skills. Due care is to be taken, that a student systematically studying the subject will acquire the skills enlisted below. A) Intellectual skills 1. Understanding the concept of experiment. (I) 2. Understanding test procedure. (Ia) 3. Interpreting the test results. (Is) 4, Understand the precautions. (le) B) Motor skills 1, Sketching of the diagrams and graphs. (Ms) 2. Measuring and recording accurately with the help of instruments or equipments. (Mz) 3. Handling and using correctly the instruments or equipments. (Ms) GRID TABLE Following table gives grid of the experiments and related intellectual and motor skills. + Teacher shall ensure for development of these skills during the practicals, + Students are expected to focus on acquiring specific skis mentioned therein. Sr Name of the Experiment Intellectual skills | Motor skills No. nb [|e [Mm [Mh [Me 1 | Know your Hospital and Clinical Pharmacy Laboratory. | V v vy Raw Material and their evaluation To prepare and evaluate Water For Injection |. P. To perform test for pyrogens on Water For Injection | P| T 7 To find out the suitability of Dextrose used for preparation v v of transfusion fluid 3 | To find out the sullabiily of Sodium Chloride used Tor preparation of transfusion fluid, by using flame photometer. © | To perform Aydrolylic resistance test on glass batlles used for transfusion fluids. v Viv fy 7 | To evaluate the plastic transfusion bottles (thickness more than 500 um) used for Large Volume Parenteral. Preparation of transfusion fluids 8 | To prepare and submit 100 mi (500ml) of 5% wiv ; v q v Dextrose intravenous infusion I. P. @ [To prepare and submit 100 mi (600 mi) of 09 % wiv Sodium Chloride intravenous infusion 1 P. v MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) Fg Name of the Experiment [intellectual skis | 50° To papas and Bit TOT aI OT oF empomne tt sodium chloride injection IP. (Ringers solution) v y 77 To prepare and submit 600 mi of compound sodium lactate injection |P. (Hartman's Solution) q ‘ T2_| To prepare and submit 100m (600m) of sodium chloride and dextrose injection LP. v 73 [To prepare and submit 100m! (600 ml) of 1.6% wiv sodium chloride hypertonic injection LP. v Y 14_[To prepare and submit 100 mil (600 mip of 14% wiv sodium bicarbonate intravenous infusion BP. v Evaluation of surgical dressing 15. | To evaluate Absorbent cotton wool LP. v v T6_| To detemine the sinking time and water holding capaciy of Absorbent cotton wool LP. vid 77_ [To determine lass on drying of Absorbent cation wool IP. | 1 | ¥ 78_| To delermine number of threads per 10cm of Absorbent cotton ribbon gauze. B. P. viv yy 1S | To determine weight per unit area of Absorbent colton ribbon gauze.8.P. yyy 20 | To determine sulphated ash of Absorbent colton wool. | V T 1p Demonstration on sterilization of hospital supplies 21 | To study the different types of sterilizers (Autoclave, q Hot air oven, Membrane fiter) 2_| To storiize surgical nstruments TI] 23_| To sterlize syringes, needles and glasswares. TT a 24_| To storiize rubber gloves and rubber tubings. T 25_| To slerize hospital fabrics T 26 | To sterilize surgical dressings. T Handling and use of data processing equipment 27. | To study the use of computers in hospital for registration a of patientin OPDIPD, case history and. preoperative via checklist. Project - 28 | To study a typical hospital organization and prepare a ‘ V projectreport Clinical Pharmacy 29. | To study the role of Pharmacist in frst ad treatment. v MARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) or Name of the Experiment Intellectual skills | Motor skills No. bb [bb [i [Mm [Me [Me 30 _ | To study the role of Pharmacist in improving patient compliance. v 31__| To study the role of Pharmacist in family planning, NOTE: ¥ Identified Skills. 'STRAGEGY FOR IMPLEMENTATION It is suggested that 40-50% experiments shall be completed in first term before winter break and remaining experiments in the second term. a MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) GUIDELINES FOR TEACHERS. Teacher shall discuss the following points with students before start of practicals ofthe subject, 1) 2) 3) 4) 5) 6) 7 8) 9) 10) 1) 12) 13) 14) 15) 16) 17) Learning Overview : To develop better understanding of importance of the subject. To know related skils to be developed such as intellectual skills and motor skils, Link | Block Diagram ; Context of the subject in the form of link diagram showing inter relationship of various subject areas, curriculum objectives and job profile. Graphical structure : In this topics and sub topics are organized in systematic way so that Ultimate purpose of leaming the subject is achieved, This is arranged in the form of fact, concept, principle, procedure, application and problem. Know your laboratory work : To understand the layout of laboratory, specifications of equipment / instruments / chemicals, procedure, working in groups, planning time etc. Also to know total amount of work to be done in the laboratory ‘Teacher shall ensure that required equipment are in working condition before start of experiment, also keep operating instruction manual available. Explain prior concepts to the students before starting of each experiment, Involve students’ activity at the time of conduct of each experiment. While taking reading / observation each student (from batch of 20 students) shall be given a chance to perform / observe the experiment List of questions is given at the end of each experiment. Teacher shall instruct the students to attempt all questions given at the end each experiment / exercise. Teacher shall ensure that each student writes the answers to the allotted questions in the laboratory manual after performance is over. If the experimental setup have variations in the specifications of the equipment, the teachers are advised to make the necessary changes, wherever needed. ‘Teacher shall assess the performance of students continuously as per norms prescribed by MSBTE, ‘Teacher should ensure that the respective skills and competencies are developed in the students after the completion of the practical exercise. ‘Teacher is expected to share the skils and competencies to be developed in the students. ‘Teacher may provide additional knowledge and skills to the students even though not covered in the manual but are expected from the students by the industries, ‘Teacher shall ensure that hospital visits are covered. Teacher may suggest the students to refer additional related literature of the technical papers / reference books / seminar proceedings, etc. During assessment teacher is expected to ask questions to the students to tap their achievements regarding related knowledge and skis so that students can prepare while submitting record of the practicals. Focus should be given on development of enlisted skills rather than theoretical / codified knowledge. \MARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) 18) Teacher should enlist the skils to be developed in the students that are expected by the industry. 19) Teacher should organize group discussions! brain storming sessions / seminars to facilitate the exchange of knowledge amongst the students. 20) Teacher should ensure that revised CIAAN-2004 norms are followed simultaneously and progressively. 21) Teacher should give more focus on hands on skills and should actually share the same, 22) Few experiments may be combined and conducted in single turn to accommodate, in given time schedule, 23) New experiments have been included as per present day requirement, even though these are not stated in the curriculum. A thought to accommodate all the experiments in the given time limit (total number of available periods) is also given, 24) Teacher shall also refer to the circular No. MSBTE/D-50/Pharma Lab Manual /2006/3160 dated (04-05-2006 for additional guidelines. INSTRUCTIONS FOR STUDENTS. ‘Students shall read the points given below for understanding the theoretical concepts and practical applications, 1) Listen carefully to the lecture given by teacher about importance of subject, curriculum philosophy, graphical structure, skils to be developed, information about equipment, instruments, procedure, method of continuous assessment, tentative plan of work in laboratory and total amount of work to be done in a year. 2) Students shall undergo study visit of the laboratory for types of equipment, instruments, chemicals be used before performing experiments, 3) Read the write up of each experiment to be performed, a day in advance, 4) Organize the work in the group and make a record of al observations. 5) Understand the workin the group and make a record ofall observations. 6) Write the answers of the questions allotted by the teacher during the same practical hours if possible or afterwards, but immediately, 7) Student should not hesitate to ask any difficulty faced during conduct of practical / exercise. 8) The students shall study all the questions given in the laboratory manual and practice to write the angwers to these questions. 9) Student shall vist the pharmaceutical industries and pathology laboratories / hospitals / medical slores and should make a project report on it, as directed by the teacher. 10) Student shall leam GMP / CGMP as expected by the industries. 11) Student should develop the habit of pocket discussion / group discussion related to the experiments / exercises so that exchanges of knowledge / skills could take place. 12) Students shall attempt to develop related hands-on-skill and gain confidence. 13) Student shall focus on development of skills rather than theoretical or codified knowledge. MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) 14) 15) 16) 17) 18) 19) 20) 21) » 2) 3) 4) ‘Student shall visit the nearby drug stores, medicinal gardens, technical exhibitions, trade fair, etc. even not included in the lab manual. In short, students should have exposure to the area of work right in the student hood. ‘Student shall insist for the completion of recommended laboratory work, pharmaceutical industrial Visits, answers to the given questions, etc, ‘Student shall develop the habit of evolving more ideas, innovations, skils ete. than included in the scope of the manual. Student shall refer periodicals / journals / pharmacopoeias, magazines, proceedings of the seminars, refer websites related to the scope of the subjects and update their knowledge and skils, Student should develop the habit of not to depend totally on teachers but to develop self learning techniques. ‘Student should develop the habit to react with the teacher without hesitation with respect to the academics involved, Student should develop habit to submit the practical exercises continuously and progressively on the scheduled dates and should get the assessment done ‘Student should be well prepared while submitting the write up of the exercise. This will develop the continuity ofthe studies and he will not be over loaded at the end of the term. ‘Special instructions while working in the laboratory ‘Student should wear apron, caps, face mask and footware. ‘Student should not taste any chemicals, crude drug, etc in the laboratory Student should not suck harmful irritants like strong acids, alkalis, organic solvent by mouth. ‘Student should handle instrument / equipment carefully in the laboratory, MARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) List of Experiments and Record of Progressive Assessment Sr Name of te Experiment Page | Daleot | Date of] Assesament ] _ Sion. of No. No, | Performance | submission | Max. Marks | Teacher & ‘0 Remarks 1 [Know your Hospital and Clinical Pharmacy 1 Laboratory. Raw Material and their evaluation 2 | To prepare and evaluate Water For Injection | 49 Le. 3 _ | To perform test for pyrogens on Water For Injection |. P. 16 [To find out the sultabilly of Dextrose used 2 for preparation of transfusion fluid 5 _ | To find out the suitabiity of Sodium Chloride Used for preparation of transfusion fluid, by | 94 Using flame photometer. © | To perform Hydrolytic resistance test on glass bottles used for transfusion fluids. 30 7 [To evaluate the plastic transfusion bolles (thickness more than 500 im) used for] 34 Large Volume Parenterals. Preparation of transfusion fluids 8 — | To prepare and submit 100 mi (500m) of | 43 5% wiv Dextrose intravenous infusion I. P. ‘S| To prepare and submit 100 mi (500 mip of 0.9 % wiv Sodium Chloride intravenous | 4g infusion |. P. TO _|To prepare and submit 100 mi (S00MI) of compound sodium chloride injection 1.P.| 53 (Ringers solution) T1__| To prepare and submit 500 mi of compound sodium lactate injection LP. (Hartmann’'s | 5 Solution) 12 [To prepare and submit 100ml (500ml) of sodium chloride and dextrose injection I.P. 13 | To prepare and submit 100m! (600 mi) of 1.6% wiv sodium chloride hypertonic | 69 injection LP. x MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clea Pharmacy (086) List of Experiments and Record of Progressive Assessment Sr Tame ofthe Experiment Page | _ Dateot | Date of | Assessment | Sign of No, No, | Performance | submission | ‘Max. Marks. | Teacher & ‘0 Remarks TE _|To prepare and submit 100 mt (500 ral) of 1.4% wlv sodium bicarbonate intravenous | 74 infusion B.P, Evaluation of surgical dressing 15 | To evaluate Absorbent cotton woo! IP. 82 16 [To determine the sinking time and water holding capacity of Absorbent cotton wool | 87 LP. 17 [To determine loss on drying of Absorbent cotton wool LP ” Te_|To determine number of threads per 10cm of Absorbent cotton ribbon gauze. B. P. 95 19 [To determine weight per unit area of ‘Absorbent cotton ribbon gauze.B.P. 86 20 [To determine sulphated ash of Absorbent cotton wool. LP. ton Demonstration on sterilization of hospital supplies 21 |To study the diferent types of sterlizers | 107 (Autoclave, Hot air oven, Membrane filter) 22_| To sterilize surgical instruments. 13 7 [To sterlize syringes, needles and glasswares. "se 24 [To sterlize rubber gloves and rubber tubings. 126 2_| To slerlize hospital Tabries 731 25 _| To slerlize surgical dressings: 134 Handling and use of data processing equipment 27 | To study the use of computers in hospital for | 49 registration of patient in OPD/IPD, case history and preoperative check list. MARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Cleical Pharmacy (086) List of Experiments and Record of Progressive Assessment SF Name of tre Experiment Page | Daloat | Date at] Assessment ] Sion. of No. No. | Performance | suomission | Max. Marks | Teacher & 10 Remarks Project 28 | To study a typical hospital organization and | 446 prepare a project report Clinical Pharmacy 29 | To study the role of Pharmacist in first aid | 55 treatment. ‘30_ | To study the role of Pharmacist in improving patient compliance, 158 31_ | To study the role of Pharmacist in family planning. 162 Total Marks obtained for the number of experiments considered for “Average marks obtained for the experiments out of 40 First Sessional (.2.2...10 s-) First Sessional ‘Second Sessional (wnt) ‘Second Sessional . Third Sessional Gund wn) Third Sessional * * To be transferred to proforma of CIAAN-2004 (Proforma I-1) Note : The guidelines for the conduct of Annual Practical Examination are enclosed in the end at page No. 166 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clic Phamacy (846) Experiment No.4 Experiment No. 1 1.0 Tith Know your Hospital and Clinical Pharmacy Laboratory 2.0 Prior Concepts: Curriculum Contents, Scope of Work, Planning, Assessment, 3.0New Concepts: Proposition 1: Laboratory experiment: Laboratory experiments are expected to develop intellectual skis, motor skills and attitudes in students ‘Concept Structure Lab. Experiments Jevelop Intellectual Skills Motor Skills Attitudes Proposition 2: Logical thinking: Logical thinking is developed in students through systems approach, content analysis and ‘sequential planning of laboratory work Concept Structure 2: ‘Systems Approach Content Analysis, Lead to Logical Thinking ‘Sequential Planning Proposition 3: Autoclaving: Autoclaving is the process of heating in which saturated steam under pressure is allowed to penetrate through the material at a temperature of 121°C for 15-20min (pressure- 15Ibs/sq.inch). ‘The measurement of time begins when the temperature of the material being sterilized reaches 121°C. Proposition 4: Hot Air Oven: ‘The process consists of subjecting the material in an hot air oven at a temperature of 170°C for ‘hour. Fats, cls, powder, glasswares, surgical catgut and surgical instruments are sterilized by this method. Proposition 5: HEPA filters: ‘They ensure laminar air flow and remove particles as small as 0.3j1m with 99.97% efficiency. MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clic Phamacy (846) Experiment No.4 Proposition 6 : All glass water still: ‘An assembly used for preparation of Water For injection. 4.0 Learning Objectives: Intellectual Skills: 1. To understand the concept of working of each laboratory equipments. 2, To interpret the results from the observations. Motor Skill: 1. Abilty to operate the instrument, 2. Abilly to observe. 3. Abilty to folow safety precautions. 5.0 Equipment : ‘Autoclave, Hot air Oven, HEPA ters, Membrane Filtration Assembly et. 6.0 Diagram : ‘Adige salty vale Airvent 5° ©) pressure gauge Seren dames {yest metalic basket tor electric mans J Fig. 1.1 Autoclave vent QUTER CASE fe ELECTRIC FAN “ASSESTOS ASBESTOS GASKET REGULATOR PERFORATED TRAYS (=> ELECTRIC HEATERS HOTAIROVEN Fig. 1.2 2 MAHARASTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clic Phamacy (846) Experiment No.4 HEPA FILTERS PROTECTIVE ‘SCREEN BLOWER Laminar air low ( Horizontal type ) Fig. 13 ent Valve Compressed | Fiterod Ar Pressure Tank Solution tobe Suodivded Aseptically Fig 1.4 Membrane Filtration Assembly MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 3Hospital and Clic Phamacy (846) Experiment No.4 |FACTURING LAYOUT OF STERILE PRODUCT MAN cy T 7a HANDLING UNITS RN yor 7 cownneanea | rmnoapseaumcanca co ae : 2 | ats Y & | meen i | | ae eee a PASSAGE — entrance JH11 PASSTHROUGH AL - Air Lock Fig. 1.5 7.0 Stepwise Procedure: 1, Read the leaming overview carefully, 2. Listen to the lecture given by teacher about importance of subject, curriculum, philosophy, graphical structure, skils to be developed, information about equipments, instruments, procedure, ‘methods of continuous assessment and tentative plan of work in laboratory. 3. Observe the sterilizing equipments ike Autoclave, Hot air oven, etc. and understand the ‘operation and purpose. 8.0 Observation: ‘Teacher should give brief idea about operation of sterlizing equipments. The students should note the following observations SrNo._] Name of the Equipment Sterilizing Temperature | Pressure | Time (-o) (Ibs/squinch) | (min) 1 Autoclave 2 Hot air oven 4 MAHARASHTRA STATE BOARD OF TECHNICAL UCATION,Hospital and Clic Phamacy (846) Experiment No.4 9.0 Questions: (Note:- Student to answer one question from category A Q eategory BQ viewers category CQ and the question numbers shall be allotted by the teacher.) Category A What is the importance of link diagram of the curriculum of the subject ? How graphical structure of a subject is useful in understanding the scope of the subject ? Classify the curriculum of diploma in diferent groups of subjects. List two roles of Pharmacists given in the job profile in block diagram. State the fact of Hospital Pharmacy given in graphical structure. Category B: 6, State purpose of Autoclaving 7. State ‘principle’ of dry heat sterilization 8. Name the method of sterilization for oly substances and dry powders. 9. What does HEPA stands for? 410. State the steriizaton temperature and time of autoclave. Category C: 11. Whatis the importance of folowing sterile wearing during sterile manufacture like Head mask, Hand gloves, Mouth piece, Apron, Foot wear. 412. State three precautions which you will take while working in aseptic laboratory? 13. List the safety precautions to be taken in the laboratory. 414, Name the departments ofthe sterile product area 415. How will you check efficiency of HEPA fiters? (Space for Answers) MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 6Hospital and Clic Phamacy (846) Experiment No.4 {Space for Answers) Date :- Signature of Subject Teacher 5 WAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Coical Phamacy (0816) Experiment No.4 1 Raw materials and their evaluation Water for injection for LP. - Itis apyrogenic distilled water intended for use in the preparations of medicines for parenteral administration. It is most extensively used vehicle in parenteral formulations. itis well tolerated by the body and ionizable electrolytes readily dissolve in water. Water miscible co- solvents such as glycerin and propylene glycol, are used as vehicles in small-volume parenteral fluids. They are used to increase the solubility of drugs and to stabilize drugs degraded by hydrolysis. Metabolizable oils are used to dissolve drugs that are insoluble in water. For example, steroids, hormones and vitamins are dissolved in vegetable oils, These formulations are administered by intramuscular injection. The major considerations in vehicle selection are : solubilty, stability and safety. . Additives : They are the solutes of highest purity, These solutes must be sterle and pyrogen free. Their purpose is to produce a safe and elegant product. Various additives, such as antimicrobial agents, antioxidants, buffers, chelating agents and tonicity adjusting agents are included in injection formulations. Drug substances = After considering water for injection, solutes, the drug substance added to the transfusion fluids are next important raw materials. i) Carbohydrates :- Dextrose, Sucrose, Dextran, etc. ii) Polyols :- Glycerol, Sorbitol and mannitol ii) Amino acids iv) Lipid emulsions which contain vegetable or semisynthetic ol \v) Electrolytes - such as sodium chloride, potassium chloride and calcium chloride, These raw materials should be highly pure. IP 1996 recommends special tests for above raw materials when they are intended to use, for preparation of intravenous infusions, Example 1. As per IP'96 Dextrose intended for use in the manufacturing of injectable preparation, should comply with the additional requirement ie. test for pyrogens. 2. Sodium chloride intended for use in the manufacturing of injectable preparation should comply with the additional requirement i. potassium NMT 0.1%, 3. Potassium chloride intended for use in the manufacturing of injectable preparation should comply with the additional requirement ie. sodium not more than 0.1% Containers and closures for parenterals ‘The containers and closures that are used for packaging parenteral products must — 1 2 3 4 Maintain the sterlly of the packed fluids. Withstand sterilization. Be compatible with the packed fluids. Allow withdrawal ofthe contents. AFARASHTRA STATE BOARD ECHNICAL EDUCATIONHospi and Ceca Phamacy (0816) Experiment No.1 Large volume parenteral fluids are packaged into 1. Glass bottles 2, PVC collapsible bags. 3. Semi rigid polythene containers. 1) Glass bottles :-Itis commonly used container for transfusion bottles. Glass is composed principally of the silicon dioxide tetrahedron, modified physico chemically by such oxides as those of sodium, potassium, calcium, magnesium, aluminium, boron and iron. The glass containers are classified as follows Type General description General use T Highly resistant borosilicate glass Buffered and unbuffered aqueous solutions. All other uses. 7 Treated soda lime glass. It is made | Buffered aqueous solutions with =H hydrolytic resistant by dealkalisation of | below 7.0, dry powders, Oleaginous the surface by surface treatment. solutions, Tr Sodalime glass. it offers moderate | Dry powders, Oleaginous solutions. hydrolytic resistance, NP General purpose soda-lime glass Not for parenterals. For tablets, oral solutions and suspensions, ointments and external liquids. Advantages 1, They are transparent and chemically inert, They may be used for products that are incompatible with plastic containers, They have high chemical resistance and resists corroding action of water, acids, bases and salts. They can be easily cleaned due to smooth surfaces. Allows checking of clarity Rigid, strong and withstands sterilization Disadvantages They are much heavier than plastic and therefore less transportable, 2. They are brittle and subject to damage during transport and storage. 3. During use they requite the use of an air-inlet fter device for pressure equilibration within the container, 4, A further problem with glass containers may occur during moist heat sterilization. This results in contamination of the fluid due to a pressure imbalance between the intemal and external environment. 2) PVC collapsible bags :- They are used to package most infusion fluids. They are designed with a port for the attachment of the administration set and an additive port for the addition of small volume parenteral fluids. a TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Ceca Phamacy (0816) Experiment No. + Advantages 41. Resistant to impact. 2. Flexible and collapse during fluid administration and so do not require an air inlet system Disadvantages 1. They permit a high moisture penetration. 2. They absorb some drugs. 3. They require an extended sterilization time due to the heat resistance of the PVC. 4. Moist heat sterilization requires air ballasting to avoid pouch explosion. 3) Somi-rigid plastic containers ~ They are used for volumes of 100 ml for electrolyte solutions, 3 litre for total parenteral nutrition solutions and upto § litre for dialysis solutions. Semi-rigid containers == i) Are more drug compatible than PVC containers. ii) Are difficutt to break, il) Do not fully collapse. iv) Needs extended heat sterlization times. v) Needs air equilibration. Rubber closures :-They are used to seal the openings of cartridges, vials and bottles, providing a material soft and elastic enough to permit entry and withdrawal of a hypodermic needle without loss of the integrity of the sealed containers. Sea mI rl Glass container Flexible plastic container Diagram of atypical administration set. AFARASHTRA STATE BOARD EDUCATIONHossa and Clinical Pharmacy (0816 Experiment No.2 1.0 20 3.0 4.0 5.0 Experiment No. 2 Titl To prepare and evaluate water for injection |P. Prior Concepts: Water, types of water, Distilation New Concepts: Proposition 1, Water for Injection is apyrogenic distilled water intended for use in the preparations of medicines for parenteral administration when water is used as a vehicle (WEFI in Buk) and dissolving or diluting substances or preparations fo injectable preparation (Sterile WF}. 2. Compliance Test for Water For Injection General Concept structure: *purteswater >| Unt” -—>} medion |—P} aspen! 1006 Learning Objectives: Intellectual Skills: 1. To understand distiation methods 2. To discriminate different types of water. 3. To understand the station unit Motor Skill: 4. Abilty to handle instrument 2. Abily to collect and preserve water. 3. Abily o interpret the tests Apparatus: Glasswares: Manesty Electrically Heated Automatic Water Stil (Stokes Still) or Simple Glass Distillation Unit, Beakers,Test tubes, Test tube holder, Pipette, Measuring cylinder, Nessler's cylinder, Stop watch, Borosilicate container. Chemicals: Methyl Red Solution, Bromothymal blue solution, alkaline potassium mercur-iodide solution, dilute ‘ammonium chloride solution, ammonia buffer pH 10.0, Mordant black II mixture, 0.01 M disodium ‘edetate, lead standard solution (1 ppm pb), 2 M nitric acid, 0.1 M silver nitrate, 10% wiv solution of potassium chloride, diphenylamine solution, sulphuric acid, nitrate standard solution (2 ppm NOs) (0.2 ppm), 2 M hydrochloric acid, barium chloride solution, 1 M Sulphuric acid, 0.02 M potassium permanganate, acetate buffer pH 3.5, Thioacetamide reagent, 7 M hydrochloric acid, 6 M Ammonia, ‘1M sodium hydroxide (prepare solutions as per IP 1996). a TWAFARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clinical Phamacy (0816) Experiment No.2 6.0 Diagram: fatal water still ‘WATER OUTLET RECEIVING ADAPTOR ‘OF GLASS RECEIVER MATER FOR INJECTION ‘Simple glass distillation unit Fig. 2.4 41. Inlet 5. Baffle 2. Condenser Tube 6. Airvent pipe 3, Condenser Jacket 7. Outlet for apyrogenic distiled water 4, Constant level attachment & Lid 9. Heating colls Fig. 2.2 Manesty Electrically Heated Automatic Water Stil (Stokes Stil) MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION "Hossa and Clinical Pharmacy (0816 Experiment No.2 7.0. Stepwise Procedure: 74 72 Water For injection is obtained by distiling potable water or purified water from a neutral glass, quartz or suitable metal stil fitted with an effective device for preventing the entrainment of droplet. ‘The stil must be suitably maintained to ensure the production of apyrogenic water. The distillate collected is stored in conditions designed to prevent the growth of micro-organisms. Preparation of Water For Injection LP. 1. Take sufficient quantity of potable water or purified water in metal water stil or glass distillation Unit of neutral glass. Boil the water using bummer or electricity Allow to form sufficient steam, Steam is condensed to Water For Injection using water condenser by distillation unit The first 50 mi portion of distilate is discarded and the remainder is collected in a suitable borosilicate container 6. Rinse the container with Water For Injection and then reject that Water For Injection. 7. Continue the process and collect the distillate in a suitable borosilicate container. 8, The Water For Injection should be used immediately forthe evaluation as per |. 1996. Evaluation of Water For Injoction as por LP. 1996: 41. Acidity or Alkalinity To 10 mi sample, freshly boiled and cooled in a borosilicate glass flask, add 0.05 mi of methyl red solution, the resulting solution is not red. To 10 ml sample , freshly boiled and cooled in a borosilicate glass flask, add 0.1 ml of bromothymol biue solution, the resulting solution is not blue. 2. Ammonium: To 20 mi sample in a borosilicate glass beaker, add 1 ml of alkaline potassium mercurtiodide solution and allow to stand for 5 minutes. When viewed vertically the solution is not more intensely colored than a solution prepared at the same time by adding 1 ml of akaline potassium mercur-iodide solution to a solution containing 2.5 ml of dilute ammonium chloride solution and 7.5 ml of the liquid being examined. 3. Calcium and Magnesium: To 100 ml sample in a borosilicate glass beaker, add 2 mi of ammonia buffer pH 10.0, 50 mg of rmordant black II mixture and 0.5 ml of 0.01 M disodium edetate, a pure blue color is produced 4, Heavy Metals: Not more than 0.1 ppm, determined by method D* Test solution -In a glass evaporating dish evaporate 150 mi to 15 mi solution on a water bath Pipette out 12 ml solution into a Nessler cylinder. “Method D: Standard Solution- Into a small Nessler cylinder, pipette out 10.0 mi of lead standard solution (1 ppm pb). Use lead standard (1 ppm pb) to prepare the standard. Procedure for heavy metal test:: To the cylinder containing the standard solution, add 2 ml of the test solution and mix.To each of the cylinders, add 2 ml ofthe acetate buffer pH 3.5, mix, add 1.2 ml of thioacetamide reagent, allow to stand for 2 minutes and view downwards over a R MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHossa and Clncal Pharmacy (0816) Experiment No.2 white surface, the color produced with the test solution is not more intense than that produced With the standard solution. 5. Chloride To 10 ml sample in a borosilicate beaker, add 1 ml of 2 M Nic acid and 0.2 ml of 0.1 M siver nitrate, the appearance of the solution does not change for atleast 15 minutes. 6. Nitrate To 5 ml in atest tube immersed in ice bath, add 0.4 mil of a 10% wi solution of potassium chloride, 0.1 ml of diphenylamine solution and add drop wise with shaking 5 ml of sulphuric acid, Transfer the tube to a water bath at 60° C and allow to stand for 15 minutes. Any blue colar in the solution is not more intense than that in a solution prepared at the same time and in the same manner using a mixture of 4.5 ml of nitrate free water & 0.5 ml of nitrate standard solution (29pm NO.) (0.2 ppm) 7. Sulphate: To 10 mi sample in a borosilicate beaker, add 0.1 ml of 2 M hydrochloric acid and 0.1 ml of barium chloride solution, The appearance of the solution does not change for alleast 1 hour. 8. Oxidisable substances: To 100 mi sample in beaker, add 10 ml of 1M suphuric acid and 0.1 mi of 0.02 M potassium permanganate and boil for minutes, the solution remains faintly pink 8. _ Residue on evaporation Evaporate 10 ml to dryness on a water bath and dry to constant weight at 105°C, The rosiduo weighs not more than 1 mg (0.001%). 8.0 Observation table: oF Name of the test ‘Observation Taferencs No. (Colour/Turbidity Appearance etc.) Rady ‘Aikalnty Test for Animoniarn Tat for Calcium & Magnesium Test for Heavy Metal Testor Chloride Test for Nitrate Test for Sulphate ‘Test for Oncisable substances Residue on evaporation 9.0 Calculation: For Residue on evaporation 1. Weight of empty porcelin dish g 2. Weight of Porcelin dish + Water for Injection = "Y' g 6 3, Weight of Porcelin dish + residue after evaporation at 108° C=°Z) g = veasend 4, Weight of residue on evaporation = (Z-X) 9 = g= % MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHossa and Clncal Pharmacy (0816) / Experiment No.2 10.0 11.0 Result : Water For Injection passef or fails the folloing test- 1. Acidity 2. Alkalinity 3. Test for Ammoniu} 4, Chloride Test 5. Test for Caleium/and Magnesium 6, Test for Nitrate 7. Test for Heavy thetals 8. Test for Sulpha| 9. Test for oxidisable substances 1 10. Residue on evaporation Questions: Q. 1. Q. and the question State the storage/conditfons for Water For Injection. Draw wel labele§ diagfams of apparatus used for Water For Injection What is metho 0? State types of wate What is purified water ? What is Sterile water for Injection 7 What is Bacteriostatic water of Injection ? How will you prepare nitrate free water 7 What is water fr Injection 2 12, Name the compliance test for Water for injection LP. 13, Whats the use of baffle’ ? 14, What is Reverse Osmosis'? 15. Why WFI should be stored at 2° C or 80°C ? 16. Why WFI should be used immediately ater its preparation ? 17. How WEI LP. is prepared ? {Space for answers) “ MAHARASHTRA STATE BOARO OF TECHNICAL EDUCATIONHosoi and Ceical Phamacy (06 Experiment No.2 (Space for answers) Date Signature of Subject Teacher MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 6Hospital and CricalPhamacy (0816) Experiment No.3 1.0 2.0 3.0 4.0 5.0 Titl Experiment No. 3 To perform test for pyrogens on water for injection IP. Prior Concepts: Parenterals, water for injection (WF), Pyrogens and their hazardous effects. New Concepts: Proposition 1: Pyrogen test Pyrogens are products of metabolism of micro-organisms. About 1 hour after injection in human beings, pyrogens produce a marked rise in body temperature, chills, body aches etc. Ger ral Concept Structure wri If pyrogens present Learning objectives: Intellectual Skills: Rise in body temp. of rabbit 1, To understand concept about sterity. 2, To understand concept about pyrogenicity, 3. To interpret the results, Motor Skills: 11, Abily to select the animal 2. Ability to handle the animal 3. Ability to locate marginal ear vein of rabbit Apparatus: Glasswares: Interpreta- results tion of > wel Passes / Fails Syringe, needle, thermometers, retaining boxes for rabbits, beakers, measuring cylinder, balance, weight box, stopwatch, Chemicals: Water for injection, Sodium Chloride. Test animals: 3 healthy adult rabbits of either sex weighing not less than 1.5 kg fed on complete and balanced diet. (Five more additional rabbits may be used if necessary). 6 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and CricalPhamacy (0816) Experiment No.3 6.0 Diagram: ABBITS, i RETAINING BOX FOR RABBITS Fig.3.1 7.0 Stepwise procedure: The Gram-negative bacteria produce the most potent pyrogenic substances as endotoxins. Chemically pyrogens are lipid substances associated with a carrier molecule, which is usually polysaccharide but may be peptide. The fever response to pyrogens in rabbits is the basis or the official pyrogens test. 7A Step 1 - Preliminary test (SHAM TEST) If animals are used forthe fist ime in a pyrogen test or have not been used during the previous two weeks, condiion them one to three days before testing the substance being examined, by injecting intravenously into them 10 ml / kg of body weight of a pyrogen free saline solution warmed to about 38.5 °C. Record the temperature of the animals beginning alleast 90 minutes before injection and continuing for three hours after injection of the solution being examined. Any animal showing a temperature variation of 0.6 °C or more must not be used inthe main tes. 72 Step l= 1, Wash all he glasswares, syringes, needles thoroughly with water for injection IP and heat in a hot air oven at 250°C for 30 minutes or at 200° for one hour. 2, Add 0.9 9 of pyrogen free sodium chloride in 100 ml of water for injection. Take the weight of each rabbit and calculate the dose as 10 mi/ kg 4. Koop the three selected rabbits in retaining boxes in such a way thatthe animals are retained by loosely fiting neck stocks and the rest of the body remains free so that the rabbits may sit in a normal position. The animals are kept into the boxes one hour before the test and remain there throughout the test 5. Insert the thermometer or temperature sensing probe into the rectum ofthe test rabbit to a depth of about 5 cms,Hospital and CricalPhamacy (0816) Experiment No.3 6. Record the temperature of each animals at intervals of not more than 30 minutes, beginning alleast 90 minutes before the injection of the solution being examined and continuing for three hours after the injection 7. Warm the water for injection which is rendered isotonic with sodium chloride to 38.5° C before injection 8. Inject the solution slowly (water for injection made isotonic) info the marginal vein of the ear of each rabbit over a period not exceeding 4 minutes 9. Record the temperature of each animal at half hourly intervals for three hours after the injection of solution. 10. Calculate the average of two temperatures, recorded at 60” minute and 90" minute, This temperature is called as ‘intial temperatute’ ofthat rabbit. 11. The highest temperature recorded for a rabbit after injection (Le. in between 120 to 270 minutes) is referred as the ‘maximum temperature! 12, Calculate the difference between maximum temperature and inital temperature. This difference is called as ‘tesponse’. (Note :- when this difference is negative, the result is counted as a zero response) 8.0 Observation table: Time starts at Time in ‘Temperature of _ | Temperature of Temperature of minutes Rabbit no. 4 Rabbit no. 2 Rabbit no. 3 TAM, 00 10:30 AM 30 11:00 AM, 60. 11.30 P.M, 90 Inject water for injection 12:00 NOON 120 12.30 PM, 150, 01:00 P.M. 780) 01.30 P.M. 210 (02:00 P.M. 240 02:30 P.M. 270 9.0 Calculations: Rabbit ] Temperature | Temperature | Inlial Temp "x | Maximum | Response of _| Sum ofall’ no. | at60"minA | at90" min B | (mean of Temp.*Y" | individual responses ‘Aand8) rabbit (Y-X) i 2 3. 10.0 Result: Intorpretation of results is done as follows- The given samples complies the test for pyrogens IP 1996. 4. Ifthe sum of the responses of the group of 3 rabbits does not exceed 1.4°C and 2, Ifthe response of any individual rabbit is less than 0.6° C % MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and CricalPhamacy (0816) Experiment No.3 Ifthe response of any rabbit is 0.6° C or more or ifthe sum of the responses of the three rabbits exceeds 1.4°6, then continue the test using s' other rabbits, then the given sample complies the test for pyrogens IP'1996- 1. ifnot more than three of the eight rabbits show individual responses of 0.6° C or more and 2. Ifthe sum of the responses of the group of 8 rabbits does not exceed 3.7°C. Results 1, The sum of the responses of three rabbits = ........°C 2. The individual response of three rabbits is PC, 8, nn 9C respectively Therefore the given sample of water for injection IP (compliesidoes not (suitable / not suitable) for comply), the test for pyrogens as per IP 1996. Hence it injectable preparations. 11.0 Questions: (Note:- Student to answer Q. a Q and the question numbers shall be allotted by the teacher.) 41. Write meaning ofthe following terms- i, Isotonic solutions ii Hypotonic solutions ii Hypertonic solutions iv, Paratonic solutions. Write the chemical nature of pyrogens. Why rabbit is chosen as an animal for pyrogen testing? Why pyrogens are more dangerous if present in large volume parenterals? State two reasons. State the procedure for LAL'S test. What is the effect of injecting hypertonic and hyotonic solutions intravenously? What is the importance of pyrogen test? State whether pyrogens are water soluble or water insoluble Are pyrogens volatile or non-volatile? 10. What does LAL stands for? 11, What are Pyrogens? (Space for Answers)Hospi and CricalPhamacy (0816) Experiment No.3 Date = (Space for Answers) Signature of Subject Teacher Pa MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Ceca Phamacy (0816) Experiment No.4 1.0 20 3.0 40 5.0 6.0 Experiment No. 4 Titl To find out the suitabilty of Dextrose for prparation of transfusion fluid, by using standard colorimetric solution. Prior Concepts : Dextrose and its types New concepts: Proposition Mothod of testing Learning Objectives: Intellectual Skill 1. To understand the concept of suitability test 2. To interpret the result Motor Skil 1. Abilty to observe the intensity of colour, Apparatus: Glassware: pair of Nessler's cylinder (50m) , Pipette , Measuring cylinder. Chemicals: Dextrose, Cobalt chloride ¢s., Copper sulphate cs. and Ferric chloride c.s., Purified water. Stepwise Procedure: Colour may be defined as the perception or subjective response by an observer to the objective stimulus of radiant energy in the visible spectrum extending over the range of 400 nm to 700 nm in wavelength. Achromicity or coloressness is one extreme of any colour scale for transmission of ight, itimplies complete absence of colour 1, Take a pair of Nessler's cylinder. 2, Inone of them prepare a solution of Dextrose by dissolving 25 g of Dextrose in purified water up to the mark of 50 ml (Sample Solution) 3. Ina 10 mi measuring cylinder, mix 1 mi of Cobalt chloride colorimetric solution, 2 ml of Copper sulphate colorimetric solution and 3 ml. of Ferric Chloride colorimetri solution and sufficient quantity of water upto 10 m 4, Take 3 mi. ofthis standard solution into second Nesslers cylinder & dilute it upto 60 ml with purified water (Standard solution). (Cobalt Chloride, Copper sulphate & Ferrie chloride colorimetric solution ae prepared as per LP. 1985, Vol. II, Appendix 144). MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION aHospi and Ceca Phamacy (0816) Experiment No.4 7.0 9.0 Observation table: After 5 minutes observe both the Nessler’s Cylinder for intensity of colour. Nesslers oylinder ‘Observe the color (darKlight brown) Nessler’s cylinder—1 (Sample) Nessler’s cylinder ~ 2 (Standard) 8.0 Result: Interpretation of resultis done as folows. Intensity of colour of sample solution is ...(lessimore) than standard solution, Hence the sample of dextrose (complies! does not comply) as per IP 1985 Question: (Note: Student to answer @....0...Q....and the Question numbers shall be allotted by the teacher.) 1. Give the range of visible spectrum 2. Explain Achromicity 3. Why itis essential to perform suitability test for Dextrose? Give two reasons. 4. Give two precaution while performing suitability test for Dextrose 5. State types of Dextrose according to LP. 6. Why Dextrose monohydrate is not used for manufacturing of Dextrose intravenous infusion? 7. Give two names of colorimetric solutions used for determination of suitability test for Dextrose. 8, Give the proportion of colorimetric solutions to be taken for performing suitability test for Dextrose, 9. What is observed and how the result is stated. lustrate the answer by giving example {Space for answers) 2 [MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospi and Ceca Phamacy (0816) Experiment No.4 (Space for answers) Date: Signature of subject Teacher MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION FyHospital and Creal Pharmacy 10 2.0 3.0 40 5.0 6.0 Experiment No.8 Experiment No. 5 Title: To find out the suitability of Sodium Chloride for preparation of Transfusion Fluid, by using flame photometer. Prior Concepts: ‘Sodium chloride and its impurity New concepts: Proposition : Flame photometer: General Concept structure: Spray of prescribed [4] Flame photometer |! concentration of alkali Metal solution jon Learning Objective: Intellectual Skills: 41. To understand the Concept of flame photometer 2, To interpret the result Motor Skills: 41. Ability to set the instruments for Zero & full scale deflection 2. Ablity to note the correct reading at deflection Apparatus: Glassware: Flame photometer, volumetric flasks (100m), Pipette, Beakers, Measuring cylinder. Chemicals: Sodium chloride, Potassium chloride, Purified water Diagram: eapout t ‘|URNER. SAMPLE SOUUTION MAHARASHTRA STATE BOARO OF TECHNICAL EDUCATIONHospital and Creal Pharmacy Experiment No 8 7.0 Stepwise Procedure: Flame Photometry Flame photometry is caled as Flame Emission Spectroscopy (FES).If a solution containing a metallic salt is aspirated into a flame, a vapour which contains atoms of the metal may be formed, Some of these gaseous metal atoms may be raised to an energy level which is sufficiently high to permit the emission of radiation characteristic ofthat metal ‘Sodium chloride intended for use in the manufacturing of injectable preparation should comply limit test for potassium as an additional requirement, The maximum limit for potassium (given by IP 96 ) is 0.1 % determined by flame photometry using 1 % wiv solution of NaCl and measuring at 768 nm. Flame photometry is based on measurement of intensity of spectral ines emitted by elements lke potassium , sodium, calcium and lithium. The sample containing these elements is dissolved in distilled water and subjected to excitation in a flame of appropriate temp and composition 7.4 Preparation of Standard Potassium Solution: (F.P.) Dissolve 1.1440 g of Potassium Chloride previously dried to constant weight at 130°C., in sufficient fresh distiled water to produce 1000 mi. This solution contains 600 microgram of potassium in 4 ml This is stock standard solution. 7.2 Preparation of sample solution: Dissolve 1 g of Sodium Chloride in fresh distiled water to produce 100 mi 7.3 Dilution Table: ‘Solution | Amount of stock] Dilution with distilled | Micro gm in 1 mi No solution (in ml) water to make it (in ml) 15 700 0 5 3 700 780 c. % 700 270 D. @ 700 360 E 75 700 450 41. Set the flame of flame photometer by adjusting entry of air and gas. Then allow flame to stabilize for about § minutes. 2. Keep all the solutions ready (sample solution and working standard solution) for use as per IP procedure. 3. Switch the instrument on. Open the lids of the filter chamber. Insert appropriate fiters for the test through the opening and close the lid Spray distilled water into the flame and adjust the galvanometer reading to zero 5. Spray the most concentrated working standard solution into the flame and adjust the sensitivity so that full scale deflection of the galvanometer is recorded. 6. Again spray distiled water into the flame for washing and when galvanometer reading is constant, readjust it to zero. 7. Now spray each working standard solution into the flame three times and record steady MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION %Hospital ard Crical Pharmacy Experiment No.8 galvanometer reading wash the apparatus thoroughly with distlled water after each spraying. 8. Spray sample solution into the flame for three times and record galvanometer reading wash the apparatus with distilled after each spraying 9. Calculate mean of galvanometer reading and plot a graph of concentration against galvanometer reading 410. Find out the concentration of potassium in the sample using graph. 11, This concentration of potassium is in microgram, so calculate for 100 mi 412. To confirm the concentration obtained from graph, repeat the operations with a standard solution of same concentration as that of the solution being examined. 8.0 Observation Table: Solution] Concentration | Galvanometer reading Mean Galvan- (inmicrogram) [Spray [1 Spray [I Spray _| meter Reading x 30 z 780 c 0 D 360 E 0 SAMPLE | Unknown 9.0 Calculation: _ GRAPH : Cone. V/S Gal. reading GS= Gal-reading of sample CS= Conc. of sample Galvanometer reaaing, Concentration in aig weaxis Note: Draw the graph of mean galvanometer reading (Y-axis) vis concentration in ug (X-axis). Find cout from the graph the value of concentration of potassium in sample solution for observed mean reading a MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital ard Crical Pharmacy Experiment No.8 Graph paper (MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 27Hospital and Creal Pharmacy Experiment No.8 10.0 11.0 Result: (Should not be more than 0.1 %) Concentration of Potassium in sample solution is. (lessimore) than 0.1% Hence the sample of sodium chloride (complies! does not comply) as per IP 1996. Questions: (Note: Student to answer Q. ..and Question numbers shall be allotted by the teacher) 4. Whatis flame photometry ? Draw block diagram of working of flame photometer. Name three parts of lame photometer. Enlist three precautions to be taken while using flame photometer. Describe Method B as per IP. Give principle of working of Flame photometer Enlist two impurities expected in sodium chloride. Give concentration of stock solutions used for determination of potassium ions concentration in sodium chloride, 9. How concentration of potassium ions in sample solution is calculated by using graph {Space for answers) 28 MAHARASHTRA STATE BOARO OF HHNICAL EDUCATIONHospital and Cnc Pharmacy (08 Experiment No.8 (Space for answers) Date: Signature of Subject Teacher MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 20Hospital and Circa Pharmacy (816) Experiment No. Experiment No. 6 1.0Title To perform Hydrolytic resistance test on glass bottles used for transfusion 2.0Prior Concept: Glass, Types of glass and its manufacturing, 3.0 New Concepts: Proposition 1: Hydrolytic Resistance Test. The test is designed to determine the resistance to water attack of new (not previously used) glass Containers, The degree of attack is determined by the amount of alkali released from the glass under the influence of the attacking medium under the conditions specified. Proposition 2: Water attack at 121°C General Concept Structure: Glass bottles with Water attack at Extract distiled water [—® | 121°C using imal autoclave v Test passes / fails Interpret the Titrate + resus + 4.0 Learning objectives: Intellectual st 1, To understand basic concept of hydrolytic resistance test. 2. To understand principle of hydrolytic resistance test. 3, To understand methods and procedures with interpretation, Motor Skills 41, Ability to fl the glass container. 2. Ability to operate Autoclave. 3, Ability to Titrate, 5.0 Apparatus: Glasswares: Glass transfusion bottles (borosilicate), petridishos (borosilicate), autoclave, burette, pipette, conical flask, Chemicals: Methyl red solution, 0.01 M Hydrochloric acid 30 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Circa Pharmacy (816) Experiment No. 6.0 Stepwise Procedure : Glass containers very easly yield alkali ons to the aqueous preparations. As parenterals are stored for long periods and in LVP’s large volume of solution is in contact with glass, considerable amount of alkali will be extracted. As no glass used for parenteral purpose is completely free from extractable alkali, itis not practicable to use a test for its complete absence. Hence limit testis used where the quantity yielded to a prescribed solution is estimated and it must be less than a specified amount. Hydrolytic resistance test is such a limit test. Dilute solutions of methyl red is yellow at about pH 6.2 and shows pink colour at about pH 4.2 and below. Hence amount of 0.01 M HCI required to give just pink colour is determined 41. Carry out the determination on the unused containers. The number of containers to be examined and the volumes of test solution to be used is as follows Table no. 4 Nominal capacity of Number of containers to be | Volume of fest solution fo be container(m used used for titration (ml) 5 or less Alleast 10 50.0 61030 Alleast 50.0 More than 30 Alleast 3 7000 2. Rinse each container alleast twice with walar at room temperature, Just before the test, rinse each container with freshly distiled water. 3. Fill the containers to the brim with freshly prepared distiled water, empty them and determine the average overflow volume. 4, Fill bottles to 90% oftheir calculated overflow volume and cover them with borosilicate glass dishes previously rinsed with freshly prepared distiled water. Place the containers in an autoclave. 6. Close the autoclave, displace the air by passing a steam for 10 minutes, raise the temperature from 100°C to 121°C over 20 minutes, maintain a temperature of 121°C for 60 minutes and reduce the temperature from 121°C to 100°C over 40 minutes, venting to prevent vacuum. Remove the containers from autoclave and cool them in a bath of running tap water. 8. Carry out the titration within 1 hour of removing the container from the autoclave, Combine the liquids from the containers being examined, measure the volume of test solution as specified in table no, 1 into a conical flask and add 0.15 ml of methyl red solution for each 60 mi of liquid 10, Titrate with 0.01M HCI (end point — yellow to pink) ‘11. Repeat the titration taking 100 mi of fresh distilled water (end point - yellow to pink) 12, Difference between the titrations represents the volume of 0.01 M HCI required by the test solution 7.0 Observation table: 41. Capacity of container (volume in each bottle) = mi 2. Volume of 0.01 M HCI for 100 mi of liquid from bottle = "X" mi = mi 3. Volume of 0.01 M HCI for 100 mi of fresh distiled water = "Y" mi = ml WARARASHTRA STATE BOARD OF TECHNICAL EDUCATION aHospital and Circa Pharmacy (816) Experiment No. 8.0 Calculations: Volume of 0.01 M HCl for 100 mi of test solution = (X— Y) ml = mi 9.0 Results: (The result is not greater than the value stated in table no. 2 as per IP 1996. ) The glass bottles used for transf (passes / fails) the hydrolytic resistance tests. 10.0 Question: (Note: Student to answer Q. numbers shall be allotted by the Q. and the question Describe the procedure of ‘powdered glass test. State the types of glass. Which type of glass withstands autoclaving and weathering? Which type of glass is used for tablets, oral solutions and suspensions, ointments and external liquids? Which type of glass is suitable for packaging non-aqueous parenteral product and powders for injection? 6. State the principle of hydrolytic resistance test. 7. Name the indicator used for hydrolytic resistance test. 8. Write chemical composition of glass. 9. Enlist steps in the manufacturing of glass container. 10. Write advantages of glass as a container for parenteral preparation, 411. Write disadvantages of glass as a container for parenteral preparation. 12, Write the characteristics of ideal container ? (Space for Answers) 2 (MAHARASHTRA STATE BOARD OF TECHNICAL EDUGATIONHospital and Circa Pharmacy (816) Exceriment No. 6 (Space for Answers) Date = Signature of Subject Teacher IWARARASHTRA STATE BOARD OF TECHNICAL EDUCATION BHospital nd Chica Parmacy (0816) Experimant No.7 Experiment No. 7 1.0 Title : To evaluate the plastic transfusion bottles (thickness more than 500 ym) used for Large Volume Parenterals using the extracts, 2.0 Prior Concepts : Plastic polymers, their types and manufacture of plastics. 3.0 New Concepts: Proposition : Compliance tests for plastic transfusion bottles are~ 41. Non-volatile matter test 2. Residue on ignition 3. Heavy metal test 4. Oxidisable substance test General Concept Structure: Plastic container |__| Subdivision into strips — Treatment with purified water + Test compliance | Separate the extract | Heat in water bath at 70°C for 24 hours as per IP 1996 4.0 Learning Objectives: Intellectual Skills: 1. To understand the concept of evaluation of plastic container. 2. To interpret the results, Motor Skills: Ability to operate an Autoclave. Abily to subdivide plastic container. 4. Ability to adjust pH & detect the end point. 5.0 Apparatus: Glasswares: OR Heat in an Autoclave at 121° C for 30 min Abily to ignite residue of sample and interpret the results of evaporation. Plastic container, water bath, scissors, Autoclave, test tube holder Type | glass measuring oylinder, beaker, glass rod, silica crucible, Nessler cylinder. Chemicals: Purified water, 1M acetic acid, 5M ammonia, lead standard solution(1ppm pb), hydragen sulphide solution, 0,002M potassium permanganate, dilute sulphuric acid, potassium iodide, 0.01M sodium thiosulphate, starch solution (Prepare solutions as per |.P. 1996) TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital nd Chica Parmacy (0816) Experiment No.7 6.0 Stepwise Procedure: Plastic containers for pharmaceutical products are made from plastics with certain additives, (antioxidants, heat stabilizers, lubricants, plasticizers, filers and colorants). During storage of transfusion fluids these additives could extract or leach into a drug solution in intimate contact with plastic container. Therefore itis necessary to evaluate the physical and chemical compatibility of a formulation in a packaging system under various storage and time conditions to ensure safety and stability of the drug products. 61 Subd ion of plas transfusion bottles: 41. Clean scissors with acetone and methylene blue, 2. From a homogenous sample of plastic material, use a portion, for each 20 ml of extracting medium, equivalent to 120 cm? total surface area (both sides combined) Subdivide into strips approximately 5 ems long and 0.3 ems wide. 4, Transfer the subdivided sample to a glass stoppered, 250 mi graduated cylinder of Type-1 glass, and add about 150 ml of purified water. Agitate for about 30 seconds, drain off and discard the liquid and repeat the operation. 6. Transfer to a suitable extraction flask a quantity of the prepared sample with a surface area of about 1200 oms* when the thickness of the sample is 0.5 mm or less OR about 600 cm? when the thickness is greater than 0.5 mm. 7. Add 200 mi of purified water and extract by heating in a water bath at 70° C for 24 hours or alternatively, heat in an autoclave at 121° C for 30 minutes. 8. Cool not below 20° C. 9, Use the extract to evaluate the following test. 6.2 Evaluation of plastic transfusion bottles as per LP. 1996: 1. Non-volatile matter: Transfer in suitable portion, 50 ml of the extract to a suitable, tared crucible (preferably a fused silica crucible that has been acid cleaned), evaporate on a water bath and dry the residue at 105°C for 1 hr. Repeat the operation with the blank; the difference between the residues obtained from the extract and the blank does not exceed 15 mg, 2. Heavy Metals: ‘Transfer 20 mi of the extract, fiter if necessary, info one of two matched Nessler cylinders, adjust the pH between 3.0 & 4.0 with 1M acetic acid or 5M ammonia, dilute with water to about 35 ml and mix Into the second Nessler cylinder add 2.0 ml of lead standard solution (1 ppm pb) and 20 ml of the blank. Adjust the pH to between 3.0 & 4.0 with 1M acetic acid or SM ‘ammonia, dilute with water to about 35 ml and mix. To each cylinder add 10 ml of a freshly prepared hydrogen sulphide solution, dilute with water 0 50 ml and mix ; any brawn color produced within 10 minutes in the cylinder containing the ‘extract is not more intense than that in the cylinder containing the lead standard solution. 3. Oxidisable substances: Transfer 20 mi of the extract into a glass stoppered flask, add 20 mil of 0.002 M potassium permanganate & 1 ml of dilute sulphuric acid and boil for 3 minutes, Cool and add 0.1 g WAFARASHTRA STATE BOARD OF TECHNICAL EDUCATION %Hospital nd Chica Pharmacy (0816) Experimant No.7 of potassium iodide, mix by shaking & allow to stand for 10 minutes in the dark. Titrate with 0.01 M sodium thiosulphate using 0.25 mi of starch solution as indicator. Repeat the operation with the blank; the difference between the two titrations is not more than 1.0 ml 7.0 Calculation: 7.4 Nonvolatile matter A. For Extracts: 41. Weight of empty crucible =” X ‘g = 9 2. Weight of crucible + extract (after complete drying) ="'Y'g =... 9 3, Weight of residue = (Y-X) g 9 B. For Blank: 4, Weight of empty crucible =" X'g 9 2. Weight of crucible + purified water (after complete drying) 3, Weight of residue = (Y-X) 9 ©. Difference between the residues obtained from the extract and the blank (AB) 7.2 Oxidisable substances: 1. Volume of 0.01 M sodium thiosulphate solution consumed by sample extract, mi 2, Volume of 0.01 M sodium thiosulphate solution consumed by blank i.e,purified wate mi. mi 3, The difference between the above two titrations is = (X-Y) ml = scenenen 8.0 Observation table: Se [Name ofthe test] Observalion Taference No. 1 Nonvolaile matter | Differences between the weight of residue g 2. Heavy metals Colour produced in test solution is darker / pale. 3, | Oxidisable Differences of volume of 0.01 M substances sodium thiosulphate consumed by sample and blank is ml 9.0 Result: ‘The plastic transfusion bottles used for Large Volume Parenterals using the extracts passes / fails the following test- 41. Non volatile matter 2. Heavy metal test 3. Oxidisable substances 10.0 Questions: (Note:- Student to answer Q. Q. Q. Q and the question ‘numbers shall be allotted by the teacher ) 1. Whatis polymer? 2. Enlist two additives in the manufacturing of plastic transfusion bottles with their role, % TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital nd Chica Parmacy (0816) Experimant No.7 Enlist two advantages of plastic for packaging over glass material Name two polymers for the manufacturing of plastic transfusion bottles. ‘State the reason for the preference of Large Density Polyethylene for squeeze bottle. Which polymer is main component of intravenous bags? What are antioxidants ? Name two examples of heat stabilizers. Name two examples of lubricants 0. Write two examples of plasticizers. {Space for Answers) WARARAGHTRA STATE BOARD OF TECHNICAL EDUCATION WHospital and Choice Pharmacy (086) Experiment No.7 (Space for Answers) Date :- Signature of Subject Teacher a TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital nd Coie Pharmacy (086) Experiment No.7 TRANSFUSION FLUIDS (INTRAVENOUS INFUSIONS) The term “Parenteral” is applied to preparation administered by injection through one or more layers of skin tissue. The word is derived from the Greek words para and enteron, meaning outside of intestine and is used for dosage forms administered by routes other than the oral route. Parenteral therapy is used to :- Produce a localized effect. vv ‘Administer drugs ifthe oral route cannot be used. Deliver drugs to the unconscious patient. Rapidly correct fluid and electrolyte imbalances, Ensure delivery of the drug to the target tissues. vv v Parenteral injections are either administered directly into blood for a fast and controlled effect or into tissues outside the blood vessels for a local or systemic effect, Parenteral products are sterile formulations that are administered into the body by various routes including injection, infusion and implantation. Injections are subdivided into small and large volume parenteral fluids. Small volume parenteral are sterile, pyrogen-tree injectable products. They are packaged in volumes upto 100 mi, Small volume parenteral fuids are packed as > Single dose ampoules > Multipte-dose vials. > Prefiled syringes Large volume parenteral products having a volume of 100 ml or greater intended to be administered by intravenous routes are called as transfusion fluids or intravenous infusions. They are formulated as single dose injections that are administered by intravenous infusions. They are sterile aqueous solutions ‘or emulsions with water for injection as the main component. Large volume parenteral products include - Infusion fluids, Total parenteral nutrition solutions. vv Intravenous antibiotics. Patient-controlled analgesia. Dialysis fds. Irrigation solutions y vy Large volume parenteral are variously formulated and packaged and have been used to v Restore fluid and electrolyte imbalance in patients suffering from dehydration, shock or injury. Provide nutrition in circumstances were patients are malnourished e.g. total parenteral nutrition, vv Act as a vehicle for administration of medicines. v Perform dialysis. Allow irrigation of body parts. v IARARASHTRA STATE BOARD OF TECHNICA UERTION %Hospital and Coca Phamacy (0816) Experiment No.7 While water for injection is the main component of these products they also incorporate other ingredients including : - > Carbohydrates, e.9. dextrose, sucrose and dextran. > Amino acids. > Lipid emulsions which contain vegetable or semi-synthetic cil > Electrolytes such as sodium chloride. > Palyols, including glycerol, sorbitol and mannitol Characteristics of sterile dosage forms > Sterility > Freedom from particulate matter > Freedom from pyrogens > Stability Isotonicity Production of large volume parenteral product :- The fluids are produced and filled into containers in @ high standard clean room environment. ‘The high standards are required to limit the contamination of these products with organisms, pyrogens and particulate matter. Use of stringent quality assurance procedure is essential to ensure the quality of the products. In commercial manufacturing facilities large volumes of fluids are used in the production of a batch of product. The fluids are packaged from a bulk container into the product container in highly mechanized operations using high speed filing machines. Just before fluid enters the containers, particulate matter is removed from the liquid by passing it through an inline membrane fiter. Immediately after filing, the neck of each bottle is sealed with a tight fitting rubber closure that is kept in place with a crimped aluminum cap. The outer cap is also aluminum and an outer tamper-evident closure is used. ‘When using plastic bags, the preformed plastic bag is aseptically filed and immediately heat sealed. As an alternative, a blow-fil-seal system can be used. This integrated system involves melting the plastic, forming the bags, filing and sealing in a high-quality clean room environment. Blow-fll-seal production decreases the problems with product handling, cleaning and particulate contamination, Following filing of the product into containers, the fluids are examined for the particulate matter and the integrity of container closures established Moist heat should be used to sterlize parenteral products, irrigation solutions and dialysis fluids wherever possible, This should be carried out as soon as possible after the containers have been fille. Plastic container should be sterlized with over pressure during the sterilization cycle to avoid the containers bursting Aseptic dispensing :- Most parenteral fluids are terminally moist heat sterilized. However, most products are aseptically ‘compounded from sterile ingredients in the hospital pharmacy. These products are prepared and dispensed for individual patients. e.g. TPN fluids and aseptic reconstitution of freeze-dried formulations. ‘These freeze-dried products are often reconstituted using either water for injection or 0.9% sodium chloride injection. Aseptic dispensing is performed in a Grade A clean room environment or Grade A @ MAFARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital nd Crical Phamacy (0818) Experiment No.7 isolator chamber, The dispensing of these products relies on good aseptic procedures to ensure the sterility of the product. Owing to the absence of terminal sterilization i is important that manufacture is performed using rigorous quality assurance procedures, Asepticaly dispensed products are given a very limited expiry time. General labeling format : Sterile pyrogen-fee ‘Single dose container Name of the preparation Batch Qty Formula Mig. Lic. No. Batch No, Mig. Date Exp. Date Retail Price not to exceed Rs. (LT. extra) For LV. use only Storage Dosage Caution Warning Name of the College IARARASHTRA STATE BOARD OF TECHNICA UEATION Fi@ Hosptaland Cina Pharmacy (818) Experiment No. 7 kwh perme tare MUECTIONE | oomumomane TWAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Ceical Pharmacy (086 1.0 Title: Experiment No. 8 Experiment No.8 To prepare and submit 100 mi (500 mi) of 5% wiv Dextrose intravenous infusion LP. 2.0 Prior Concepts : Dextrose and its types, Intravenous infusion, sterlization, single dose container. 3.0 New Concepts: Proposition 41, Method of preparation, 2. Method of sterilization 3. Labeling General Concept Structure 4.0 Learning objectives: Intellectual Skills: 1, To understand basic concept of sterility. 2. To understand precautions to be taken during sterile manufacturing preparations, Motor Skills: 1. Abily to fl the bottles, 2. Ability to inspect the product, 3. Abilly to handle sterilization equipment. 5.0 Apparatus: Glasswares: Glass bottles, beaker, funnel, volumetric flask, glass rod, rubber closures, aluminium seals, crimping machine, autoclave, weight box, chemical balance. Chemicals: Dextrose, Water for injection. Dissolve ‘Weigh in vehicle Filter [> Fil Inspect Label Sterlise IARARASHTRA STATE BOARD OF TECHNICA UERTION BHospial and inca Pharmacy (058) Experiment No.8 6.0 Stepwise procedure: Dextrose intravenous infusion is a sterile solution of Dextrose in Water For Injection I.P. Usual strengths are 5% wiv, 10% wiv, 25% wlv and 50% wiv. It is a large volume single dose injectable preparation, so it contains no antimicrobial agents. There are two forms of Dextrose in the Pharmacoposia-Dextrose (anhydrous) and Dextrose (monohydrate). The monohydrate form is not sufficiently pure for the preparation of injections and on autoclaving its solution become brown due to caramelization. Anhydrous form is sufficiently pure than monohydrate and is used for preparation of transfusion fluids. Step-| Formula Dextrose Injection |.P. contains not less than 95.0 percent and not more than 105.0 percent of the stated amount of anhydrous dextrose. Dextrose anhydrous LP. 59 Water For Injection |. 100 mi Calculations: 4100 mi of Water For Injection requires 5 of Dextrose. Therefore, 500 ml of Water For Injection requires X' g of Dextrose Xx 100 = 5 x 500 X=259 Stepll 4. Take accurately weighed quantity of Dextrose in the suitable sterlized container and add sufficient quantity of Water For Injection to make the required volume. Stir to dissolve 2. The solution should be clear, int, fiter the solution using sintered glass filters, Fill the clear fitered solution into ss pressure tank and aseptically pass through membrane fier of 0.22 pm. Fil the solution aseptically into steriized transfusion bottle. Close with steriized rubber closure and seal with aluminum cap. 4. Invert and shake the bottle to check leakage. Reject leaked bottles. Examine the solution critically for particles. 5. Carry out the sterilization in an autoclave, with usual precautions under following conditions. Holding temperature T20C Holding pressure Tbs /sqinch Holding time 20 min 6. Switch off the Autoclave, Allow it to cool and the pressure to come down to zero, before opening the autoclave to remove the bottles 7. Polish the bottle and re-examine for the particles, check the label and stick onthe bottle 8, This solution should comply with the specifications laid down by the LP. 6.4 Category / Use- Itis frequently used in nutrition and / or fuid replacement therapy. # TWAPARASHTRR STATE BOARD OF TECHNICALHospital ana Clncal Pharmacy (0816 Experiment No.8 6.2 Storage- Store in a cool dark place, protected from light 6.3 Dosage- As directed by the physician. To be used with non-pyrogenic |.V. administration set with aseptic technique. 6.4 Caution- Even invisible damage to container caused during transit, storage or handling may result in contamination. Do not use if container is found leaking or solution is hazy or solution contains visible solid particles. 6.5 Warning- Discard any unused portion 6.6 Direction For LV. use only. 7.0 Observation table: ‘SeNO- | Ingredients ‘Quantities Prescribed Calculated 1 Dextrose anhydrous IP. 59 z Water Far Injection IP. 100 ml 8.0. Lable: (Note: The students should make the label as per one of the labelling formats given on page no. 41 under the guidance of the teacher) (Space for label) MARARASHTRA STATE BOARD OF TECHNICAL EDUCATION 3Hospial and ince Pharmacy (058) Experiment No.8 9.0 Resul 5% wiv Dextrose intravenous infusion LP. was (prepared, sterilized, labelled and submitted.) 10.0 Questions: (Note:- Student to answer Q. Q a and the question numbers shall be allotted by the teacher.) 1. What does LVP and SVP stand for? 2. Write two uses of large volume parenteral. 3. What is Terminal sterilization? 4. State two forms of Dextrose. Which form is suitable for preparation of intravenous infusions and. why? What is single dose container? Why antimicrobials are not added in single dose containers? Name two antimicrobial agents added in muliple-dose preparation, What are the characteristics of parenteral products? Write the sterlization temperature and time of the sterilizing equipment autoclave, Write principle of moist heat sterilization. Write two merits and demerits of moist heat sterilization. 12. Name three tests to be complied for Dextrose intravenous infusion as per LP. 1996. 13. State the pH of Dextrose intravenous infusion as per LP. 1996. 14, Why transfusion fluids are made isotonic with blood plasma? 16, How transfusion fluids are made isotonic with blood plasma? 16. What is caramelization ? (Space for Answers) z TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospialand CinicelPrarmacy (8 Experiment No.8 Date :- (Space for Answers) Signature of Subject Teacher IARARASHTRA STATE BOARD OF TECHNICA EDUCATION aHospi and Chica Pharmacy (086 Experiment No Experiment No. 9 1.0. Title: To prepare and submit 100 ml (500 ml) of 0.9% wiv Sodium Chloride intravenous infusion LP. 2.0 Prior Concepts : Intravenous infusion, types of steriization, single dose containers, its importance 3.0 New Concepts: Proposition : 41 Method of preparation 2 Method of sterilization 3 Labeling General Concept Structure Dissolve Weigh [>] invehisle [> Fiter >) Fi >) Inspect Label Steriise 1. Intellectual Skills: 1. To understand basic concept of sterility 2. To understand precautions to be taken during sterile manufacturing preparations, Motor Si Abiity to fil inthe bottles. 2, Ability to inspect the product 3. Ability to handle sterization equipment 4. Ability to prepare label. 5.0 Apparatus Glasswares: Glass bottles, beakers, rubber closures, aluminium seals, crimping machine, autoclave, weight box, chemical balance, funnel, volumetric flask, glass rod. Chemicals: Sodium Chloride, Water For Injection. 6.0 Stepwise procedure: Sodium Chloride Injection isa sterile 0.9% wiv solution of Sodium Chloride in Water For Injections. It contains no antimicrobial agents; as itis a large volume and single dose parenteral preparation. Step-| Formula: ‘Sodium Chioride Injection contains not less than 0.85% wiv and not more than 0.95% wiv of sodium chloride, NaCl Sodium Chloride 09g Water For Injection 1P 4100 mi @ WAARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospi and Chica Pharmacy (086 Experiment No Calculations: 100 mi of Water For Injection IP requires 0.9 g of Sodium Chloride Therefore, 500 mi of Water For Injection IP requires X' g of Sodium Chloride X x 100=0.9 x 500 ie. X = 0.9x500 100 X= 4.5 g of Sodium Chloride step-ll 1. Take accurately weighed ,required quantity of Sodium Chloride in the suitable sterilized container and add sufficient quantity of Water For Injection to make the required volume . Stirto dissolve 2, The solution should be clear, if not, fiter the solution using sintered glass fiers, 3, Fill the clear filtered solution into ss pressure tank and aseptically pass through membrane filer of 0.22 um. Fill the solution aseptically into sterilized transfusion bottle. Close with sterilized rubber closure and seal with aluminum cap. 4. Invert and shake the bottle to check leakage. Reject leaked bottles. Examine the solution critically for particles. 5. Carry out the sterilization in an autoclave with usual precautions under following conditions. Holding temperature 126C Holding pressure TS ibs sqinch Holding ume 20min 6. Switch off the Autoclave. Allow it to coal and the pressure fo come down to zero, before opening the autoclave to remove the bottles. 7. Polish the bottle and re-examine for the particles, check the label and stick on the bottle. 8, This solution should comply with the specifications laid down by the LP. 6.1 Category / Use- Fluid and electrolyte replenisher. 6.2 Storage- Store in a cool dark place, protected from light. 6.3 Dosage- ‘As directed by the physician. To be used with non-pyrogenic LV. administration set with aseptic, technique. 6.4 Caution- Even invisible damage to container caused during transit, storage or handling may result in contamination. Do not use if container is found leaking or solution is hazy or solution contains visible solid particles 6.5 Warning- Discard any unused portion 6.6 Direction- For LV. use only. IAPARASHTRA STATE BOARD OF TECHNICA UCATION BiHospi ang Chica Pharmacy (086 Experiment No 7.0 Observation table: Sr. | Ingredients ‘Quaniiies No, Prescribed Calculated 1_| Sodium Chloride 029 2_[ Water For Injection LP. 700 mi 8.0 Calculation: Label: (Note: The students should make the label as per one of the labeling formats given on page no. 41 under the guidance of the teacher) (Space for label) 9.0 Result: 0.9 % wiv Sodium Chloride intravenous infusion LP. was (prepared, sterilized, labeled and submitted) 10.0 Questions: (Note:- Student to answer Q. Q Q numbers shall be allotted by the teacher.) and the question 4. ‘0.9% wiv sodium chloride solution is isotonic with blood’ State whether 0.5% wlv solution is. hypotonic or hypertonic.? What willbe the effect on RBC's if such a solution is administered intravenously. 2. What is isotonicity? 3, What is Normal Saline Solution? 4, ‘If sold visible particle is observed in the sterilized and sealed bottle of normal solution’, what ‘suggestion should be given to the patient? WARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Ceca Phamacy (0816) Experiment No 5. ‘Ifthe normal saline solution is administered withthe nonsterle IV administration set state whether itis correct or incorrect. 6. Name two tests to be complied for Sodium Chloride intravenous infusion as per .P. 1996, 7. State the pH of Sodium Chloride intravenous infusion as per LP. 1996. 8. Write the sterilization temperature and time ofthe sterilizing equipment, Autoclave 8 Which type of containers are used for intravenous infusion? (Space for Answers) IAPARASHTRA STATE BOARD OF TECHNICA UCATION aiHospi and Chica Pharmacy (086 Experiment No (Space for Answers) Date == Signature of Subject Teacher @ TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHosptial and Clea Pharmacy (016) 1.0 20 3.0 40 5.0 6.0 Experiment No. 10 Title: To prepare and submit 100 mi (500 ml) of Compound Sodium Chloride intravenous infusion I. Prior Concepts: Intravenous infusion, types of sterilization, single dose container, its importance. New Concept Proposition : 41 Method of preparation 2 Method of sterilization 3 Labeling Genoral Concept Structure Weigh > nah vt > Filter Label }¢—{ Steriise |¢—{ inspect je Learning objectives : Intellectual Skills: 1, To understand basic concept of sterility. 2. To understand precautions to be taken during sterle manufacturing preparations. Motor Skills: 4. Abily ofl the bottles. 2. Abiliy to inspect the product. 3. Abilly to handle steriization equipment. 4, Abilly to prepare label. Apparatus: Glasswares: Glass bottles, beaker, rubber closures, aluminium seals, crimping machine, autoclave, weight box, ‘chemical balance, funnel , volumetric flask, glass rod Chemicals: Sodium Chloride, Potassium Chloride , Calcium Chloride Water For Injection Stepwise procedure: Compound Sodium Chloride injection IP. isa sterile solution containing 0.86 % wiv of Sodium Chloride, 0.03 % wiv of Potassium Chloride and 0.033 % of Calcium Chloride in Water For Injection t contains no antimicrobial agents; as itis a large volume and single dose parenteral preparation. IARARASHTRA STATE BOARD OF TECHNICA UERTION BHosptial and Clea Pharmacy (016) Step-! Formula: Compound Sodium Chloride injection |.P. contains not less than 0.82% wiv and not more than 0.9% wiv of sodium chloride, NaCl, not less than 0.0285 % wiv and not more than 0.0315 % wiv of, Potassium chloride, KCI and not less than 0.030 % wiv and not more than 0.036 % wiv of Calcium Chloride, CaCl. 2H,0. Sodium Chloride 0.88 g Potassium Chloride 0.0309 Calcium Chloride 0.033 g Water For Injection IP 100 mi Calculations: 100 mi of Water For Injection IP requires 0.86 g of Sodium Chloride Therefore, 500 ml of Water For Injection IP requires ‘X’ g of Sodium Chloride X x 100 = 0.86 x 500 ie. X = 0.86 x 500 100 X= 4.3 g of Sodium Chloride Similarly , calculate the quantiies required for ther ingredients. Step-t 1. Take accurately weighed ,tequired quantity of Sodium Chloride, Potassium Chloride and Calcium Chloride inthe suitable sterilized container and add sufficient quantity of Water For Injection to make the required volume . Strto dissolve, 2. The solution should be clear, ifnot, iter the solution using sintered glass fiters. 3. Fill the clear fitered solution into ss pressure tank and asepticaly pass through membrane fiter of 0.22 um. Fil the solution aseptically into sterilized transfusion bottle. Close with sterilized rubber closure and seal with aluminum cap. 4. Invert and shake the bolle to check leakage. Reject leaked bottles. Examine the solution citically for particles. 5. Carry out the stelization in an autoclave with usual precautions under folowing conaiions Holding temperature TPC Holding pressure 15 lbs sqinch Holding time 20min 6. Switch off the Autoclave. Allow itto cool and the pressure to come down to zero, before opening the autoclave to remove the bottles. 7. Polish the bottle and re-examine for the particles, check the label and stick on the bottle. 8, This solution should comply with the specifications laid down by the | P. 6.4 Category / Use- Irrigation solution (for external use) , Fluid and electrolyte replenisher. 6.2 Storage- Store in a tightly closed containers, in cool dark place, protected from light. TWAFARASHTRA STATE BOARD ECHNICAL EDUCATIONHosptial and Clea Pharmacy (0816) Experi Nos0 6.3 Dosage- {As directed by the physician. To be used with non-pyrogenic LV. administration set with aseptic technique. Even invisible damage to container caused during transit, storage or handling may result in contamination. Do not use if container is found leaking or solution is hazy or solution contains visible solid particles. 6.5 Warning- Discard any unused portion, 6.6 Direction- For LV. use only. 7.0 Observation table: Sr, | Ingredients ‘Quantities No. Prescribed Calculated 1_| Sodium Chionde: 0.86 g 2_| Potassium Chloride 0.030 g '3_| Calcium Chloride 0.033 “4 [Water For Injection LP. 400 ml 8.0 Calculation: Label: (Note: The students should make the label as per one of the labeling formats given on page no. 41 under the guidance of the teacher). {Space for label) IAPARAGHTRA STATE BOARD OF TECHNICA UCATIONHosptial and Clinica Pharmacy (0816) Experi 9.0 Resul Compound Sodium Chloride intravenous infusion LP. was (prepared, sterlized, labeled and submitted), 10.0 Questions: (Note:- Student to answer Q.o...:.@ ‘numbers shall be allotted by the teacher.) Q......0 and the question 1, What is the synonym of Compound Sodium Chloride intravenous infusion |.P. ? 2. What is the composition of Ringer Solution ? 3. Give the formula for 250 mi of Compound Sodium Chloride intravenous infusion LP. ? 4, Name two tests to be complied for Compound Sodium Chloride intravenous infusion as per Lp. 1996. State the pH of Compound Sodium Chloride intravenous infusion as per I.P, 1996. 6. Write the sterilization temperature and time ofthe sterilizing equipment, Autoclave 7. Out of lag time, sterilization hold time and cooling time, which time can not be modified by operator of autoclave. 8. Write the category of Compound Sodium Chloride intravenous infusion LP, ? 9. What do you mean by sintering point ? 410. What are sintered glass fiter ? 11, Write two advantages of sintered glass fiter 12. Write two disadvantages of sintered glass fiter 13, Draw a well neat diagram of sintered glass filter (Space for Answers) 5 WARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHosptial and Clinica Pharmacy (0816) Experiment No10 (Space for Answers) Date :- Signature of Subject Teacher WARARASHTRA STATE BOARD OF TECHNICAL EDUCATION aHospital and Clic Pharmacy (0816) Experiment No. 11 1.0 20 3.0 4.0 5.0 Experiment No. 11 Title: ‘To prepare and submit 500 ml of Compound Sodium Lactate Injection LP. (Hartman's solution) Prior Concepts Intravenous infusion, sterilization, single dose container. New Concepts: Proposition 41. Method of preparation. 2, Method of sterilization. 3. Labeling General Concept Structure Dissolve weigh |) invehice [| Fitter [> Fil Inspect Label [4 Steriise Learning objectives: Intellectual Skills: 1, To understand basic concept of sterily 2, To understand precautions to be taken during stele manufacturing preparations. Motor Skills: 1. Ability to fil the bottles. 2. Abily to inspect the produet. 3. Abiity to handle steriization equipment. Apparatus: Glasswares: Glass bottles, conical flask, beaker, pipette, volumetric Nask, funnel, glass rod rubber closures, aluminum seals, crimping machine, autoclave, weight box, chemical balance Chemicals: Lactic acid, sodium hydroxide, sodium chloride, potassium chloride, calcium chloride, dilute hydrochloric acid, phenol red solution, Water for injection. 58 WAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Cnical Pharmacy (0818) Experiment No. 11 6.0 Stepwise procedure: Prineiple: Last acid and sodium hyéroide react to form sodium lactate coon OONa HCH < + Nao = ———> Hacc oH oH Laci Acid Sodium Lactate But, lactic acid contains a small proportion of anhydrides. These anhydrides are hydrolysed back to lactic acid by subjecting it to autoclaving temperatures in presence of a slight excess of the alkali, The excess of alkali remaining after autoclaving is neutralized by dilute HCI and pH comes between 5 to 7. During preparation sodium hydroxide should be weighed as fast as possible because sodium hydroxide is, deliquescent and if sodium hydroxide added contain large water, it may not leave excess of NaOH after autoclaving. Compound sodium lactate injection is slightly hypotonic, but may be made isotonic by addition of appropriate amount of sodium chloride. Step-1 Formula Lactic acid 24 ml Sodium hydroxide 1159 Dilute Hydrochloric acid a sufficient quantity Sodium chloride 60g Potassium chloride 04g Calcium Chloride 027g Water for injection qs. 41000 mi Calculations: 1000 ml of Water For Injection requires 2.4 ml of Lactic Acid Therefore 500 ml of Water For Injection requires X ml of Lactic Acid. Xx 1000 = 2.4 x 500 x 2m Similarly, calculate the quantities required for other ingredients, Step I 1, Take the accurately weighed quantity of sodium hydroxide into a sterilized conical flask and dissolve it in 100 mi of Water For Injection. 2, Add the calculated quantity of lactic acid to it and heat in an autoclave at 115* C ~ 116°C for | hr. 3. Allow the solution to cool and cautiously add dilute hydrochloric acid (about 1 mi) until 0.15 ml of the solution gives a full orange color with 0.05 ml of phenol red solution, 4, Dissolve the calculated quantities of sodium chloride, potassium chloride and calcium chloride into 360 mi of Water For Injection, into a suitable sterilized container. 5. Mix the two solutions of step 3 and 4 into a suitable sterilized container and add sufficient quantity of Water For injection to produce the required volume 500 mi 6. The solution should be clear, if not, fter the solution using sintered glass filters. WAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION wHospital and Cnical Pharmacy (0816) Experiment No. 11 7. Fillthe clear fitered solution into ss pressure tank and aseptically pass through membrane fiter of 0.22 um. Fill the solution aseptically into sterlized transfusion bottle. Close with sterilized rubber losure and seal with aluminum cap. 8, Invert and shake the bottle to check leakage, Reject leaked bottles, Examine the solution critically for particles. 9. Carry out the sterilization in an autoctave, with usual precautions under following conditions. Holding temperature T26C Holding pressure Tbs sqinch Holding time 20 min 10. Switch off the Autoclave. Allow it fo cool and the pressure to come down to zero, before opening the autoclave to remove the bottles. 11, Polish the bottle and re-examine for the particles, check the label and stick on the bottle, 12. This solution should comply with the specifications laid down by the LP. 6.1 Category / Use- Fluid and Electrolyte replenisher. 62 Storage Store in a cool dark place, protected from light 63 Dosage: ‘As directed by the physician. To be used with non-pyrogenic LV. administration set with aseptic technique. 6.4 Caution- Even invisible damage to container caused during transit, storage or handing may result in ‘contamination. Do not use if container is found leaking or solution is hazy or solution contains visible solid particles, 6.5 Warning- Discard any unused portion. 66 Direction- For LV. use only. 7.0 Observation table: ‘SeNo, | Ingredients ‘Quantities Prescfibed Calculated 1 Tactic Aca 2A ml z ‘Sodium hydroxide 1159 3 Dilute hydrochloric acia Sufficient quantity a Sodium Chloride 609g 5 Potassium Chloride 04g @ Calcium Chloride 0279 7 Water For Injection 4.5. 1000 mi 0 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Cnical Pharmacy (0818) Experiment No. 11 8.0 Label: (Note: The students should make the label as per one of the labelling formats siven on page no. 41 under the guidance of the teacher) {Space for label) 9.0 Result: Compound sodium lactate injection LP. was (prepared, sterilized, labelled and submitted.) 10.0 Questions: (Note:- Student to answer Q. Q ‘numbers shall be allotted by the teacher.) . and the question \Write the synonym of compound sodium lactate injection IP. Why sodium hydroxide should be weighed as fast as possible during preparation? Name the tests compound sodium lactate injection I.P. has to comply as per I.P. 1996. State the pH of compound sodium lactate injection LP. What do you mean by aseptic technique? What do you mean by sterlization? 'WAFARASHTRA STATE BOARD OF TECHNICAL EDUCATION coHospital and Cnical Pharmacy (0818) Experiment No. 11 7. Name the indicator used in “Hartman's Solution” 8, Why sodium hydroxide is added in slight excess quantity in the step 1? 9. Why dilute hydrochloric acid is added in step 3.2 410. Write the advantage of sodium lactate over sodium bicarbonate. 11, What is the use of laminar alr low bench ? 42. What are the different sources of contamination in parenterals ? (Space for answers) @ MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clinical Pharmacy (0818) Experiment No. 11 (Space for Answers) Date :- Signature of Subject Teacher WARARASHTRA STATE BOARD OF TECHNICAL EDUCATION 8Hospital and Clinical Pharmacy (086) Experiment No, 12 1.0 20 3.0 40 5.0 6.0 Experiment No. 12 Title: To prepare and submit 100 mi (500 ml) of Sodium Chloride and Dextrose Injection IP Prior Concepts : Dextrose and its types, Injection , sterilization, single dose container. New Concepts: Proposition 4, Method of preparation. 2, Method of steiization 3. Labeling General Concept Structure Weigh Dissolve Filter Fill invehicle. [—>) > Label }e—{_ Steriise /¢—{ inspect Learning objectives: Intellectual Skills: 1. To understand the basic concept of sterility. 2. To understand precautions to be taken during sterle manufacturing preparations. Motor Skills: 4. Abiliy ofl the bottles. 2. Ability to inspect the product 3. Ability to handle stelization equipment. 4, Abilty to propare label Apparatus: Glasswares: Glass bottles, volumetric ask, rubber closures, aluminium seals, crimping machine, autoclave, weight box, chemical balance, funnel volumetric fask, glass rod Chemicals: Sodium Chloride, Dextrose, Water For Injection. Stepwise procedure: ‘Sodium Chloride and Dextrose Injection |.P. is a sterile solution of Sodium Chloride and Dextrose in Water For Injection IP, Indian Pharmacopoeia recommends 13 different strengths of Sodium Chloride and Dextrose. Its a large volume single dose parenteral preparation soit does not contain antimicrobial agent. Overage is not necessary. Dextrose anhydrous is used for preparation ofthis Injection TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Clinical Pharmacy (086) Experiment No, 12 ‘Step-l Formula- Sodium Chloride and Dextrose Injection ILP. contains not less than 95.0 percent and not more than 105.0 percent of the stated amount of Sodium Chloride, NaCl and anhydrous dextrose, Cs H1z05 Sodium Chloride LP. 089. Dextrose anhydrous LP. 59. Water For Injection LP. 100 ml Calculations: 100 mi of Water For Injection requires 0.9 g of Sodium Chloride g of Sodium Chloride Therefore, 500 ml of Water For Injection requires Xx 100 = 0.9.x 500 X= 45 g of Sodium Chloride. Similarly , calculate the quantities required for other ingredients, Step: 1, Take accurately weighed ,required quantity of Sodium Chloride and Dextrose in the suitable sterilized container and add sufficient quantity of Water For Injection to make the required volume. Stir to dissolve. The solution should be clear, if not, filter the solution using sintered glass fiters. 3. Fill the clear fitered solutir fo ss pressure tank and aseptically pass through membrane filter of 0.22 um. Fil the solution aseptically into steriized transfusion bottle, Close with sterilized rubber closure and seal with aluminum cap. 4, Invert and shake the bottle to check leakage. Reject leaked bottles. Examine the solution critically for particles. '5. Carry out the sterlization in an autoclave, with usual precautions under folowing conditions. Holding temperature T2rC Holding pressure TB lbs /squinch Holding tme 20 min 6. Switch off the Autoclave, Allow itto cool and the pressure to come down to zero, before opening the autoctave to remove the bottles. 7. Polish the bottle and re-examine for the particles, check the label and stick on the bottle, 8, This solution should comply with the specifications laid down by the LP. 6.1 Category / Use- Nutrient, Fluid and electrolyte replenisher. 6.2 Storagt Store in a cool dark place, protected from light, 63 Dosag ‘As directed by the physician. To be used with non-pyrogenic LV. administration set with aseptic, technique ‘WAAARAGHTRA STATE BOARD OF TECHNICAL EDUCATION SHospital and Cla Pharmacy (0 Experiment No, 12 Even invisible damage to container caused during transit, storage or handling may result in contamination 6.5 Warning- Do not use if container is found leaking or solution is hazy or solution contains visible solid particles. Discard any unused portion. 66 Direction. For LV. use only, 7.0 Observation tabl ‘SeNo_ | Ingredients ‘Quantities Prescribed Calculated 7 Sodium Chloride IP. 08a 2 Dextrose anhydrous 1P. 5a 3__ | Water For Injection 1P. 700 ml 8.0 Calculat Label: (Note: The students should make the label as per one of the labeling formats given on page no. 41 under the guidance of the teacher.) {Space for Label) 9.0 Result: Sodium Chloride and Dextrose Injection LP. was. (prepared, sterlized, labeled and submitted). % MAHARASHTRA STATE BOARD OF HNICAL EDUCATIONHospital and lca Pharmacy (086) Experiment No, 12 10.0 Questions: (Note:- Student to answer Q. .Q Q and the question numbers shall be allotted by the teacher.) 1, Write two merits of Moist Heat Sterilisation ? Write two demerits of Moist Heat Sterilsation ? State the pH of Sodium Chloride and Dextrose Injection LP. List two characteristics of parenteral preparations ? Write two advantages of Large Volume Parenterals Write four routes of administration of Parenteral Products ‘What are the advantages of intravenous Injection? Write two advantages of parenteral preparations. Write two disadvantages of parenteral preparations. How many different strengths of NaC! and dextrose does ILP. recommends ? Mention any two. 11. What do you mean by electrolyte replenisher 7 (Space for Answers) ARARASHTRA STATE BOARD ECRNIGAL EDUCATION aHospital and Clncal Pharmacy (086) Experiment No, 12 Date :- (Space for Answers) Signature of Subject Teacher = MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONfxg and Cical Phemacy (0816) Experiment No.13, Experiment No. 13 1.0 Tith ‘To prepare and submit 100 ml (500 ml) of 1.6 % wiv Sodium Chloride hypertonic Injection LP. 2.0 Prior Concepts : Intravenous infusion, types of striization, single dose containers, is importance. 3.0 New Concept: Proposition : 1 Method of preparation 2 Method of steriization 3 Labeling General Concept Structure Weigh Dissalve in vehicle Filter Fill foil > Fits >| Label_}¢—] steriise |e Insoect 4.0 Learning objectives : Intellectual Skis: 1. To understand basic concept of sterility 2, To understand precautions to be taken during sterle manufacturing preparations Motor Skills: 1. Ability to fill in the bottles. 2, Ability to inspect the product 3. Ability to handle stelization equipment. 4. Ability to prepare label 5.0 Apparatus: Glasswares: Glass bottles, beaker, rubber closures, aluminium seals, crimping machine, autoclave, weight box, chemical balance, funnel, volumetric flask, gla rod. Chemicals: Sodium Chloride, Water for Injection. 6..0 Stepwise procedur 1.6 % wiv Sodium Chloride hypertonic Injction LP. is a colourless clear, non pyrogenic single dose large volume parentral solution contains 1.6 % of Sodium Chloride in Water for Injection It contains not less than 1.62 % wlv and not more than 1.68 % wlv of Sedium Chloride, NaCl. It contains no antimicrobial agents; a its @ large volume and single dose parenteral preparation. ‘Step Formula 1.6 % wiv Sodium Chloride hypertonic Injection IP, contains Sodium Chloride 169 Water For Injection IP 4100 mi MAHARASHTRA STATE BOARD ECHNIGAL EDUCATION cylxptal and Cnical Phemacy (0816) Experiment No.13, Caleulations: 100 mi of Water For Injection IP requires 1.6 g of Sodium Chloride Therefore, 500 ml of Water For Injection IP requires ‘X’ g of Sodium Chloride X x 100 = 1.6 x 500 Le. X= 4.6.x 500 100 X= 8.0 g of Sodium Chloride Step-tl 4. Take accurately weighed,required quantity of Sodium Chloride in the suitable sterilized container and add sufficient quantity of Water For Injection to make the required volume Stir to dissolve 2. The solution should be clear, ifnot, iter the solution using sintered glass titers 3. Fil the clear fitered solution into ss pressure tank and aseptically pass through membrane fier of 0.22 um. Fil the solution aseptically into sterilized transfusion bottle. Close with sterlized rubber closure and seal with aluminum cap. 4, Invert and shake the bottle to check leakage. Reject leaked bottles. Examine the solution critically for particles. 5. Camry out the steriization in an autoctave with usual precautions under following conditions. Holding temperature T20C Holding pressure 15 lbs / sqinch Holding time 20min 6, Switch off the Autoclave. Allow it to cool and the pressure fo come down to zero, before opening the autoclave to remove the battles. 7. Polish the bottle and re-examine for the particles, check the label and stick on the bottle. 8, This solution should comply with the specifications laid down by the LP. 64 Category / Use- Fluid and electrolyte replenisher. 62 Storage ‘Store in single dose containers of glass or plastic, in cool dark place, protected from light. 6.3 Dosage- AAs directed by the physician, To be used with non-pyrogenic I.V. administration set with aseptic technique. 6.4 Caution- Even invisible damage to container caused during transit, storage or handling may result in contamination. Do not use if container is found leaking or solution is hazy or solution contains visible solid particles. On keeping small solid particles may separate from a glass container. 6.5 Warning- Discard any unused portion. 66 Direction- For LV. use only, w WAFARASHTRA STATE BOARD OF TECHNICAL EDUCATIONeal and Cia Phamacy (0816) Exponent No 13, 7.0 Observation table: Sr. | Ingredients ‘Quantities No, Prescribed Calculated 1 _| Sodium Chloride 16 9 2_[ Water For Injection IP. 700ml 8.0 Calculation: Label: (Note: The students should make the label as per one of the labeling formats given on page no. 41 under the guidance of the teacher ). {Space for label) 9.0 Result: 1.6 % wiv Sodium Chloride hypertonic Injection I.P. was, (prepared, sterlzed, labeled and submitted), 10.0 Questions: (Note:= Student to answer Q. a, a, and the question ‘numbers shall be allotted by the teacher.) 1. What are paratonic solution ? 2. What is hypertonicity ? 3, How transfusion fluids are made isotonic with blood plasma ? 4, Name two tests to be complied for 1.6 % wiv Sodium Chloride hypertonic injection as per LP. 1996, 5. State the pH of 1.6 % wiv Sodium Chloride hypertonic injection as per IP. 1996. 6. Inwhat condition 1.6 % wiv Sodium Chloride hypertonic injection is injected ? 7. What is leaker test ? iARARASHTRA STATE BOARD TECHNICAL EDUCATION 7fxg and Cical Phemacy (0816) Experiment No.13, (Space for Answers) % TWARARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital and Cnc Phamacy (816) experiment No 13, {Space for Answers) Date :- Signature of Subject Teacher ‘MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION 7Hospital ang Ceca Phamacy (0816) Experiment No, 4 Experiment No. 14 1.0 Title: To prepare and submit 100 mi (500 ml) of 1.4 % wiv Sodium Bicarbonate Intravenous Injection BP. 2.0 Prior Concepts : Sodium Bicarbonate and its physical properties, steization, single dose container, metabolic acidosis and metabolic alkalosis. 3.0. New Concepts: Proposition 4. Method of preparation. 2. Method of sterlization. 3, Labeling General Concept Structure Dissolve in Filter Sterlise Weigh >) vehicle ial Label bt Inspect fe Fill 4.0 Learning objectives: Intellectual Skills: 1, To understand the basic concept of sterility. 2, To understand precautions to be taken during sterle manufacturing preparations Motor Skills: 4. Abilty to fil the bottles. 2. Ability to inspect the product. 3. Abily to steiize by using membrane fiter assembly. 4. Abilty to propare label 5.0 Apparatus: Glass wares: Glass bottles, volumetric flask, rubber closures, aluminium seals, rimping machine, Membrane fier assembly, weight box, chemical balance, funnel, volumetric flask, glass rod Chemicals: Sodium Bicarbonate, Water For Injection 6.0 Stepwise procedure: Sodium Bicarbonate Intravenous Infusion B.P. is a sterle solution of Sodium Bicarbonate in Water For Injection. Unless and otherwise specified, a solution containing 1.4 % wiv of Sodium Bicarbonate is supplied 7 WAHARASHTRA STATE BOARD OF TECHNICAL EDUCATIONHospital ang Ceca Phamacy (0816) Experiment No, 4 ‘Step Formula ‘Sodium Bicarbonate Intravenous Infusion B.P. contains not less than 94.0 percent and not more than 106.0 percent of the stated amount of Sodium Bicarbonate, NaHCO, ‘Sodium Bicarbonate 149 Water For injection 100 mi Calculations: 100 ml of Water For Injection requires 1.4 g of Sodium Bicarbonate Therefore, 500 ml of Water For Injection requires 'X’ g of Sodium Chloride Xx 100 = 1.4.x 500 x Step-ll g of Sodium Bicarbonate, 1. Take the accurately weighed, required quantity of Sodium Bicarbonate in the suitable sterilized container and add sufficient quantity of Water For Injection to make the required volume. Stir to dissolve 2. The solution should be clear, if not, iter the solution using sintered glass fiters, 3. Fillthe clear ftered solution into ss pressure tank and aseptically pass through membrane filter of 0.22 4m. Fill the solution aseptically into sterilized transfusion bottle. Close with sterilized rubber closure and seal with aluminum cap. 4. Invert and shake the bottle to check leakage, Reject leaked bottles. Examine the solution critically for particles. 5. Polish the bottle and re-examine for the particles, check the label and stick on the bottle. 6. This solution should comply with the specifications laid down by the B.P. 6.1 Category / Use- Systemic Alkaliser, electrolyte replenisher. 62 Storage ‘Sodium Bicarbonate Intravenous Infusion should not be kept in containers that have previously been subjected to heating in an autoclave. 6.3 Dosage- ‘As directed by the physician. To be used with non-pyrogenic I.V. administration set with aseptic technique. 6.4 Caution. Even invisible damage to container caused during transit, storage or handling may result in contamination 6.5 Warning- Do not use if container is found leaking or solution is hazy or solution contains visible solid particles Discard any unused portion. 66 Direction- For LV. use only, WARARASHTRA STATE BOARD OF TECHNICAL EDUCATION 7576 Hospital and ical Pharmacy (081 7.0 Observation table: Experiment No, 4 Sr] Ingredients Quantities No. Prescribed Calcutated ‘Sodium Bicarbonate 149 z Water For Injection TOO mi 8.0 Calculation: Label: (Note: The students should make the label as per one of the labs under the guidance of the teacher. ) given on page no. 441 (Space for Label) 9.0 Result: ‘Sodium Bicarbonate Intravenous Infusion 8.P. was, (prepared, sterilized, labeled and submitted). 10.0 Questions: (Note:- Student to answer Q 1a numbers shall be allotted by the teacher.) 1. What is sterilisation ? 2, State the types of sterilisation ? 3. Write two examples of preparation sterilsed by mechanical method of sterilisation, and the question MAHARASHTRA STATE BOARO OF TECHNICAL EDUCATIONHospital ang Ceca Phamacy (0816) Experiment No, 4 4. Name the fiters used in mechanical sterilsation method. 5. What are membrane fiters made up of ? 6. What do you mean by systemic alkaliser ? 7. What is Aseptic Technique? 8. Write two precautions while working in Aseptic laboratory to prevent contamination 9. What is Total Parenteral Nutrition (TPN) ? (0. What will happen if Sodium Bicarbonate is sterilized by Moist heat sterilization ? 14, Gan Sodium Bicarbonate Intravenous Infusion be sterlized by Dry heat Sterlization? 42. State the condition in which Sodium Bicarbonate Intravenous Infusion is prescribed 13. Whats the pore size of membrane fier used for sterilization of Sodium Bicarbonate Intravenous Infusion ? 14, Why positive pressure is maintained in sterile area ? (Space for Answers) FWARARASHTRA STATE BOARD OF TECHNICAL EDUCATION 7Hospital and Cia Pharmacy Experiment No, 4 Date :- (Space for Answers) Signature of Subject Teacher TWAHARASHTRA STATE BOARD OF TECHNICAL EDUGATIONHospital and Cnical Pharmacy (0816) Experiment No. 14 Evaluation of surgical dressings ‘Surgical dressing is aterm applied to a wide range of materials used for the dressing of wounds or injured or diseased tissues. Dressings are used to- provide an environment for wound healing. prevent maceration by permitting evaporation or absorption. promote haemostasis. protect the wound from further damage. reduce heat los. control microbial growth promote autolysis, promote healing, 8. provide compression, promoting, haemostasis and reducing edema, 10. provide support. 111, reduce pain, increase patient comfort 12. reduce odour. 13. improve the appearance of the wound site, 14, reduce overall costs associated with wound treatment, A good surgical dressing should be porous to water, can absorb excess secretion, non-adherent to ‘granulating surfaces, free from foreign irtants, obstruct to micro-organisms and outside fluid Classification of surgical dressings :- ‘Surgical dressings may be classified as follows 1. Fibres 2.9, Absorbent cotton, nonabsorbent cotton, surgical cotton, cotton balls, nonabsorbent bleached cotton ete. 2. Fabrics €.9. Absorbent lint, absorbent cotton gauze, absorbent ribbon gauze, flamated gauze, medicated surgical gauze pads, x-ray detectable gauze pads, sanitary napkins, eye pads ete. 3. Bandages @.9. Gauze roller bandages, muslin bandage rolls, elastic bandages like crepe bandage, high bulk bandage, triangular bandage, orthopedic bandage, plaster of paris bandage etc. 4. Adhesive tapes e.g, Rubber based adnesive tapes, acrylate adhesive tapes, zinc oxide surgical adhesive tapes, permeable plastic surgical adhesive tapes etc. ‘The following surgical dressings are official in Indian Pharmacopoeia, 1996 41. Absorbent Cotton LP. > ‘Synonym : Absorbent Cotton Wool. Absorbent cotton consists of trichomes or good quality new combers obtained from the seed coats of various species of the genus Gossypium Linn: cleaned, purified and bleached. It does not contain any compensatory colouring matter. MAHARASHTRA STATE BOARO OF TECHNICAL EDUCATION 73Hosp and Chica Phamacy (0816) Experiment No, 14 Description :- White, well-carded fibres of average staple length not less than 10mm, containing not more than traces of leaf residues, seed coats and other impurities. It offers appreciable resistance when pulled and does not shed a significant quantity of dust when shaken gently; practically odourless. Packaging :- Package in rolls of not more than 500 g of continuous lap, with a light-weight paper running under the entire lap, the paper being of such width that it may be folded over the edges of the lap, the two together being tightly and evenly rolled, enclosed and sealed in a well-closed container. Category - surgical dressing, Specification tests as per .P. 1996 1. Identification tests. Test for acidity or alkalinity Test for surface-active substances. Absorbency test Fluorescence test Test for coloring matters, Test for ether soluble substances. Test for water soluble substances, 9. Test for Neps. 410. Test for suiphated ash 11, Test for loss on drying. 2. Absorbent Lint P ‘Synonym : - Lint, Cotton Lint, unmedicated lint Absorbent lint is a cotton cloth of plain weave, on one side of which a nep has been raised from either warp or weft yams, It absorbs water readily but its absorbency may be considerably reduced by medication, the absorbency of the product depending upon the medicament incorporated Category : Surgical dressing Description -- Cotton with of plain weave, reasonably free from weaving defect, readily tearable in both direction and bleached to a good white having on one side a nep raised from either the warp or weft yams and reasonably free from neps, itis clean and reasonably free from leaf shell and other foreign substances. It is made of yarn which is reasonably free from slubs, snarls and other defects. Storage ‘Store in well-closed packages so as to prevent access of moisture,in a dry place, free from dust Labeling : The label states that the dimensions viz. the length and width in cm, Specification Tests as per LP. 1996 1. Absorbency test 2, Fluorescence test 3. Threads per em i) Warp not ess than 16 ii) Welt not less than 10 4. Weight per unt area 25 g has a superficial area of 1350 to 1370 sq.cm. 3. Absorbent Cotton Ribbon Gauze B P. Definition ; Absorbent cotton ribbon gauze consist of woven fabric supplied as ribbon of various width 80 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION