PhCare 331: Hospital Pharmacy

Distribution System (Part 2)

1) Individual Prescription Patient Medications (Individual Labeled Prescription for each Patient, or Individual Inpatient
Prescription System)--- A drug distribution system wherein all drugs are retained in the pharmacy until the order is
received, and then a multiple dose supply is dispensed to the nursing unit labeled for use by a specific patient.

Other distribution systems in hospital

2) Floor Stock System - A system wherein bulk- supplies of each drug product is maintained on the nursing unit in advance
need and nurse prepares the doses for administration.
**Emergency Cart (e-cart) or crash cart -- a cart stocked with emergency medical equipment, supplies, and drugs for
use by medical personnel especially during efforts to resuscitate a patient experiencing cardiac arrest; It usually
contains the following medications:

Amiodarone 150 mg vial

Aspirin 81 mg tabs
Atropine 8 mg/20 ml vial
Benadryl 50mg
Dextrose 50% (25% in pediatric medication drawers)
Diazepam 50 mg/10 ml
Dopamine 40 mg/ ml
Epinephrine (e.g., EpiPen, Epinephrine 1:1,000)
Lidocaine 100 mg
Lopressor 10 mg
Midazolam 50 mg/10 ml vial
Naloxone (e.g., Narcan 1 mg/ml)
Nitroglycerin spray or 0.4mg sublingual tablets (3)
Vasopressin 20u/ ml
3) Decentralized automation – (satellite pharmacy: Disadvantage, requires additional staff and equipments)
4) Unit Dose System--is a system medications are dispensed for administration to a specific patient, in a specific dose, at a
specific time, on a regular basis. In this system, each dose is individually prepared, packaged, and labeled.

In hospitals, the forms are somewhat different and are referred to as medication orders. In a typical medication
order sheet, the orders and instructions are written by the physician in ink. Please refer to the sample on the next page.
The medication order generally contains the following information:
• Doses: including the quantity of a prescribed dose, the total number of doses prescribed, and the number of days the
prescribed medication will last.
• Compliance: the patient’s or caregiver’s compliance in meeting the prescribed directions for dosing.
• Drug concentration: the quantity of an active therapeutic ingredient to use to achieve the
desired drug concentration.
• Rate of drug administration: the quantity of drug administered per unit of time to meet prescribed
dosing schedule (e.g., mg/min, drops/minute, or mL/hr for the administration of an
intravenous fluid).
• Compounding: the quantities of active and inactive components to use in the extemporaneous
preparation of a pharmaceutical product, including the use of stock solutions and/or prefabricated
dosage units in the process.
• Chemical-physical factors: including calculations to make solutions isotonic, iso-osmotic, equimolar,
or buffered.
• Pharmacoeconomics: including medication costs, cost-benefit analysis, cost-effectiveness analysis,
alternative treatment plans, and medication pricing.

It is the responsibility of the pharmacist to ensure that each prescription and medication order received is correct in its form
and content; is appropriate for the patient being treated; and is subsequently filled, labeled, dispensed, and administered
accurately. In essence, each medication should be:

• therapeutically appropriate for the patient;

• prescribed at the correct dose;
• dispensed in the correct strength and dosage form;
• correctly labeled with complete instructions for the patient or caregiver; and
• for the patient in a hospital or other health care facility, each medication must be administered to the correct patient, at the
correct time, and by the correct rate and route of administration.

Note: Please make sure that you have mastered the different abbreviation!
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Drug Dosage Calculations

Drug doses vary between drug substances; there are drugs that have small doses, some drugs have large
doses. The dose is based on its biochemical and pharmacologic activity, physical and chemical properties, dosage
form, route of administration, and several patient factors, such as patient’s age, weight, body surface area, general
physical health , liver and kidney functions, and the illness being treated.

Definition of terms:

Dose - the quantitative amount of a drug administered or taken by a patient for the intended medicinal
effect.
Single dose – the amount of a drug taken at one time.
Total dose – the amount of drug taken during the time-course of therapy.
Dosage regimen – the schedule of dosing such as; four times a day for 10 days
Usual adult dose – the amount of a drug that originally produces the medicinal effect intended in adults.
Usual pediatric dose – the amount of a drug that originally produces the medicinal effect intended in
infants or child patient.
Median effective dose - the amount of a drug that produces the desired intensity of effect in 50% of the
individuals tested.
Median toxic dose – the amount of a drug that produces toxic effect in 50% of the individuals tested.
Minimum effective concentration (MEC) – the minimum blood serum concentration of a drug that can
be expected to produce the drug‘s desired effects in a patient.
Minimum toxic concentration (MTC) – the base level of blood serum concentration of a drug that
produces dose-related toxic effects.
Priming or loading dose – the dose larger than the usual initial dose that may be required to achieve the
desired blood drug level.
Maintenance dose – dose which is similar in amount to usual doses, and administered according to the
dosage regimen to sustain the desired drug blood levels or drug effects.
Prophylactic dose – a dose that protects the patient from contracting a specific disease.
Therapeutic dose - a dose that counter a disease after exposure.

Pediatric Dosage
Pediatrics is the branch of medicine that deals with disease in children from birth through adolescence.

Neonate (newborn)----------from birth to 1 month

Infant--------------------------1 month to 1 year
Early childhood--------------1 year through 5 years
Late childhood---------------6 years through 12 years
Adolescence -----------------13 years through 17years
Premature---------------------a neonate born at less than 37 weeks

A number of factors affect the proper dosing of drugs for pediatric patients which include the age and weight of
the patient, over all health status, the condition of biologic functions (e.g., respiration and circulation), and the

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stage of development of body systems for drug metabolism (e.g., liver enzymes) and drug elimination (e.g., renal
system). In neonates, the biologic functions and systems are underdeveloped yet. The renal function develops
during the first 2 years of life.

Pharmacokinetic data (i.e., the rates and extent of drug absorption, distribution, metabolism, and elimination)
together with individual patient drug handling characteristics, and therapeutic response, are important in the
calculation of doses for pediatrics.

Drug Dosage Based on Body Surface Area

The body surface area (BSA) method of calculating drug dose is used in cancer patients receiving chemotherapy,
and in pediatric patients. The neonates are not included, because, their dose is based on weight, age, and other
factors such as biochemical, physiologic, pathologic, and immunological factors. The body surface area (BSA) can
be determined by using a chart called nomogram.

The following equations are useful in the calculation of dose based on body surface area is:

Patient’s dose = Patient’s BSA (m²) X adult dose

1.73 m²

Patient’s dose = Dose per m² x patient’s BSA (m²)

Patient’s BSA (m²)= √ patient’s height (cm) x patient’s weight (kg)

3600

References:

Ansel, Howard . 2010. Pharmaceutical Calculations. 13th edition. Philadelphia, Walnut Street: Lippincott Williams and Wilkins.

Brown, T. (2010). Introduction to Hospital and Health-System Pharmacy Practice. Bethesda: American Society of Health-System
Pharmacists
Gennaro, A. et.al. (2000). Remington’s Pharmaceutical Sciences, 20th ed., 2000, Pennsylvania: Mack Publishing Company.

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Distribution System
- Refers to a system that has a purpose of
selection, acquisition control, storage,
dispensing, delivery, preparation, and
administration of drug product in health care
institution in response to an authorized
prescriber.
• Centralized – Main pharmacy
• Decentralized – Satellite pharmacy
• Outpatient – individual prescription
• Inpatient – individual prescription and medical
order; Floor stock (charge or non-charge); unit
dose drug delivery system.
Unit dose drug delivery system
- Those medications ordered, stored, packed,
handed, administrated, and charged in multiples
of single dose units containing a predetermined
amount of a drug or supply sufficient for one
regular dose.
- A single unit package is one which contain one
complete pharmaceutical dosage form.
- Example: 1 tablet or 1 capsule
- Note: UDDS Pharmacist will provide the 24-hour
consumption of the patient.
Advantages:
• Less drug losses.
• More accurate inventory, cost accounting and
charging.
• Decreases incidence of medication error.
Dose
- Quantitative amount of drug administered or
taken by a patient for the intended medicinal
effect
Patient Requiring Special Dosing
Pediatric
• Weight
• Age
• Overall status
Geriatric
• Weight
• Age
• Organ function
Pediatric Dose Calculation
• Young’s Rule
(Age in years/age in years + 12) (adult dose)
• Clark’s Rule
(Weight in pounds/150) (adult dose)
• Fried’s Rule
(Age in months/15) (adult dose)
• Cowling’s Rule
(Age in the next birthday/24) (adult dose)
Pediatric Dose Calculation
• BSA (Nomogram)
Patient dose = [BSA (m2)/1.73 m2] [adult dose]
Patient dose = [Dose per m2] [patient’s BSA
(m2)]
Equipment Used in Dosage Measurement
• Medicine cup
• Calibrated dropper – every drug package has
distinct dropper which should not be
interchanged.
• Measuring spoon – household spoons vary in
size and are not reliable for accurate dosing.
• Syringe for oral use – to be safe, do not use
syringe intended for injections in the
administration of oral medications. Confusion
about the route of administration occur.
• Syringe for injection – top of the rubber part.
- 3 mL → calibration is 0.1 mL
- 1 mL → calibration is 0.01 mL
- 100 units → 100 units/mL
- 5 mL → calibration is 1mL
- 10 mL → calibration is 2 mL
- 20 mL → calibration is 1 mL
- 30 mL → calibration is 1 mL
- 60 mL → calibration is 1 mL
- 100 mL → calibration is 2 mL
- Pre-filled single-dose syringe
- Safety syringes
- Needleless syringes
• Inhalers
Drug Product Labels
Content of the Label
• Generic and Brand Name
• Dosage Form and/or Supply Dosage
• Total Volume
• Route of Administration
• Direction for Reconstitution and Label Alert
• Name of Manufacturer
• Lot and Expiry Number
• NDS or Control Substance Schedule
Brand Name & Generic Name
Dosage Strength
Dosage Form
Supply Dosage
Total Volume
Route of Administration Reconstituted Label
(Date and time of reconstitution, strength. Expiration and
storage, initials of the compounder)
02/21/13,1600, reconstituted as 225 mg/mL. Expired
02/22/13, 1600. Store at room temperature. C.M.F.

Label Alert

Name of Manufacturer

Expiration Date
Lot Number

NDC Code
Control Substance Schedule

Direction for Mixing or Reconstitution

 PhCare 331: Hospital Pharmacy

Powder Form Drugs for Parenteral Use and for Oral Solution or Suspension

Drug manufacturers prepare some drugs, especially antibiotics, in dry powder form, since these drugs lose their
potency in a short period of time when they are in liquid form. These preparations need to be reconstituted with a
specific solvent such as purified water for oral use, and sterile water for injection, bacteriostatic water for injection,
0.9% sodium chloride injection, or other specific solvents for parenteral use, as stated on the label of the drug
product or on the drug insert. They are reconstituted at the time a prescription or a medication order is received.
These preparations are available for both parenteral and for oral use.

Parenteral Use

The parenteral products contain only limited amount of specified added ingredients to increase stability and
effectiveness ( no colorants, flavorants, sweeteners, etc.are added). So, the bulk volume of the dry contents of a
vial is largely or entirely the medication. Generally, these medications are small-volume products intended for use by
injection or as additives to large volume parenterals.

If the dry powder, because of its small quantity, does not significantly contribute to the final volume of the
constituted solution , the volume of the solvent used will approximate the final volume of the solution. For example,
if 1000 units of dry drug powder are to be dissolved , and if the powder does not account for any significant portion
of the final volume, the addition of 5- mL solvent produces a solution containing 200 units / mL.( Stoklosa and Ansel)

If the dry powder is bulky, and it contributes to the final volume of the constituted solution, the increase in volume
produced by the drug must be considered, which is then be used in calculating the amount of solvent needed to
prepare a solution of a desired concentration. For example, a vial containing 1 G of dry powder of streptomycin
sulfate needs 4.2 mL of sterile solvent to be added to the dry powder to produce 5 mL of a solution which contains
200 mg./ mL. The drug accounts for 0.8 mL of the final volume.

Rules for reconstituting injectable medications from powder to liquid form:

Rule 1. Carefully check the instructions, expiration date, and vial label for the appropriate diluents.
Rule 2. Determine both the type and the volume in mL of diluent to be used for the route as ordered.
Rule 3. Verify the length of drug potency.
Rule 4. Note the resulting supply dosage on the vial.
Rule 4. Reconstitute the drug.
Rule 5. For multiple-dose injectable medications, store the reconstituted drug appropriately with a
reconstitution label attached.

Sample: Procedure for reconstituting injectable medications in powder form:

Example: Kefzol (cefazolin) reconstitution procedure to fill the order: cefazolin 225 mg IV q 6h

1. Inject 2 mL air into sterile water diluents vial

2. Withdraw 2 mL sterile water
3. Add the 2- mL sterile water to cefazolin 500 mg powder and shake well.
4. Withdraw 1 mL cefazolin solution for the ordered dosage of 225 mg.
5. Prepare a reconstitution label if needed.

Powder Form Drugs for Parenteral Use Reconstitution label

When you mix a multiple-dose vial of medication in powdered form, it is important that the vial be clearly labeled.
The reconstitution label must contain the following:
1. date and time of preparation – example: 02/21/13, 1600
2. supply dosage – example: 225 mg/mL; 250 mg/5mL
3. length of potency – is different from the expiration date. It indicates how long the drug may
be used after reconstitution.

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Example of length of potency:
“ Reconstituted solution is stable for 24 hours at or below room temperature (86°F) and 7 days when refrigerated.”
The expiration date is provided by the manufacturer on the label of thedrug product. It
indicates the last date the drug may be reconstituted and used.
4. storage directions – example: Keep refrigerated; Store at room temperature
5. initials of the person who prepared the mixture – example: R.P.L.(initial for Rey P. Lot)
Example: reconstitution label for Kefzol
Example:

Parenteral Drugs in Solution

The term parenteral refers to the injectable routes of administration. It designates routes of administration
other than gastrointestinal. Injections are sterile pharmaceutical solutions or suspensions of a drug substance in an
aqueous or nonaqueous vehicle. They are administered by needle into almost any part of the body, including the
joints (intra-articular), joint fluid (intrasynovial), spinal column (intraspinal), spinal fluid (intrathecal), arteries (intra-
arterial), and in an emergency, even the heart (intracardiac). However, most injections are administered into a vein
(intravenous, I.V., IV), muscle (intramuscular, I.M., IM), skin (intradermal, I.D., ID, intracutaneous), or under the skin
(subcutaneous, sub- Q, SQ, hypodermic). Depending upon their use, injections are packaged in small volumes in
ampuls or in prefilled disposable syringes for single-dose use; in vials and pen-injectors for single- or multiple-dose
use; or in large volume plastic bags or glass containers for administration by slow intravenous infusion.

Parenteral ( Gk, para enteron, beside the intestine) dosage forms are injected directly into body tissues
through the primary protective system of the human body, skin, and mucous membranes. Parenteral medications
must be sterile and free from pyrogens and particulate matter. Pyrogens are fever-producing organic substances
arising from microbial contamination and are responsible for many of the febrile reactions which occur in patients
following intravenous injection.
Most parenteral medications are prepared in liquid or solution form and packaged in vials, ampules, or
prefilled syringes. Vials are glass or plastic containers closed with a rubber stopper and sealed with an aluminum
crimp. Ampules are glass containers which have a neck portion with a score line. The score line is used as a guide in
breaking the glass to separate it from the body of the container, without producing any fragments of the glass. Any
unused portion of the opened ampule must not be used at a later time, since the sterility of the contents becomes
questionable already.
Hypodermic syringes are used to administer parenteral medications. Its capacity usually ranges from 2- to
50-mL capacity. Disposable hypodermic syringes are also available. They are mostly used outside of a hospital
setting.
The first crude instrument for parenteral therapy or injection of medication under the skin was a needle
trocar, developed to deposit morphine in paste form.
Tuberculin syringe is a small syringe not exceeding 1 mL in capacity and graduated in 0.1- or 0.01- mL
divisions.
Insulin syringe is a syringe calibrated in units and used in the administration of insulin.
Needles are also called cannulas. Hypodermic needles have been made of stainless steel, hyperchrome steel,
chromium, nickeloid, platinum, platinum-iridium, silver, or gold. A long-bevel or long- taper needle is used for local
anesthesia, aspirating, hypodermoclysis, and subcutaneous administration. A short-bevel needle is used for
intravenous administration, infusions, and transfusion. A special short-bevel needle is employed for intradermal and
spinal administration.

Regular needles are measured for length from where the cannula joins the hub to the tip of the point (hub not
included).

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The gauge of the needle is measured by the outside diameter of the cannula or needle shaft. The usual range of
diameter for needles is from 13-gauge (largest diameter) to 27-gauge. Needles are seldom less than ¼ inch long or
longer than 3 ½ inch.

Route Gauge Length Volume to be injected

biopsy and bone 16-gauge ½ inch
marrow transfusion to 19-gauge to 3 ½ inch
local anesthesia 26-gauge ½ inch
to
20-gauge 6 inches
intravenous, blood 19-gauge 1 ¼ inch
transfusion to
15-gauge 2 ½ inch
intramuscular 20-gauge 2 inches 2 mL – maximum
to to volume in the deltoid
22-gauge 3 inches 5 mL – maximum
volume in the gluteal
region
subcutaneous 24-gauge 3/8 inch 1.3 mL – maximum
to to volume that can be
26-gauge 1 inch comfortably injected
(> 2 mL – most likely
cause painful pressure)
subcutaneous insulin 25-gauge 5/16 inch
to to
30-gauge 5/8 inch
intradermal 23 gauge 0.1 mL – usual volume
to 3/8 inch
26 gauge

Intravenous (IV) infusions are sterile, aqueous preparations administered intravenously in relatively large
volumes. They are used to extend blood volume and/or provide electrolytes, nutrients, or medications. Most
intravenous infusions are administered to critical care, infirm, dehydrated, or malnourished patients, or to patients
prior to, during, and/or following surgery. Intravenous infusions are widely employed in emergency care units, in
hospitals and other patient care;

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Rate of Flow of Intravenous Fluids

On medication orders, the physician specifies the rate of flow of intravenous fluids in milliliters per minute, drops per
minute, amount of drug (as milligrams per hour), or, more frequently, as the approximate duration of time of
administration of the total volume of the infusion. Pharmacists may be called on to perform or check rate-of-flow
calculations as those described in the following example problems in this section.
Oftentimes, the following equation finds use in rate-of-flow calculations:

In common usage are macro sets that deliver 10, 15, or 20 drops per milliliter and microdrip or minidrip sets that deliver 60 drops
per milliliter.

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Bulk Compounding & Preparation of Sterile Products
- Some hospital pharmacies operate
manufacturing program:
• Galenical pharmaceuticals
• Products not commercially available
• Sterile solutions for topical use
• Collyria, ointments
• Small volume injectable solutions
• Sterile products:
→Surgical irrigating fluids
➔ Large volume injectable solutions
➔ Special sterile products for
investigational use
- Manufacturing program within the hospital
pharmacy:
• Reduces the cost of pharmaceuticals to the
patient.
Points to consider in the manufacturing
a. Budgetary control
- Regulate economic aspects
b. Quality control
- Govern quality, purity, and strength.
Total Parenteral Nutrition (TPN)
- Intravenous administration of calories, nitrogen,
and other nutrients in sufficient quantities to
achieve tissue synthesis and anabolism.
- Provides all of the patient’s daily nutritional
requirements.
Partial Parenteral Nutrition (PPN)
- Supplements oral intake and provides only part
of daily nutritional requirements.
Parenteral Nutrition (PN)
- 2500/day → approximate normal calorie
requirement for an adult
- 1L of D5W → contains 50 g dextrose/L
equivalent to 170 calories.
- To reduce fluid volume → increase concentration
of dextrose to D25W.
Carbohydrate dextrose
- Preferred source for calorie in PN fluid.

Crystalline Amino acids

Factors considered to develop adequate budgetary
control over the manufacturing program: - Source of Nitrogen in PN fluids.
- Examples:
• Consumption rate for finished product
• Aminosyn (Abbott)
• Raw materials requirements
• FreeAmine III (B. Braun)
• Manufacturing capacity
• Travasol (Baxter)
• Available personnel
• Operating cost (direct & indirect cost)
Usual Electrolyte Concentration:
• Sodium = 100 – 120 mEq
Enteral feeding
• Potassium = 80 -120 mEq
- Direct infusion of nutrients into the intestine in
liquid form. • Magnesium = 8 – 16 mEq
- Less expensive • Calcium = 5 – 10 mEq
- Low potential to cause serious complications • Chlorine = 100 – 120 mEq
• Phosphate = 40 – 60 mEq

Enteral Nutrition Product

- Administered orally via: PN Guidelines
• Nasogastric tube (nose – stomach) • Electrolyte requirement vary with individual
• Gastrostomy (opening into stomach) patient.
• Needle-catheter jejunostomy (opening into • Electrolyte present in amino acids (label)
the jejunum) • Better to keep 1:1 ratio (Na & Cl ions)
- Formulated to contain: • If the combination of Calcium and
• Variety of vitamins Phosphate ions exceeds 20 mEq,
• Minerals precipitation occurs.
• Carbohydrates • Water soluble & fat-soluble vitamins may be
• Proteins added usually in a form of multivitamin
• Fats infusion concentrate.
• Caloric requirements • Iron is administered separately from PN
- Examples: fluids.
• Ensure • IV orders are usually written 24-hr therapy
period.
• Ensure plus
• Patient’s chart is reviewed and new orders
• Ensure with Fiber
are written daily.
- Specific enteral products are selected according
to the patient they serve: • Admixture (prepared by pharmacist or
supervised technician)
• Within 2000-3000 cal/day (poor appetite or
with cancer) • Prescription is checked for proper dose,
drug allergies, compatibility, stability.
• Daily caloric needs exceed 3000 cal (high
protein losses from severe trauma like burns • Additives are given an expiration period of
or sepsis). 24 hours from time of preparation.
• Label (affixed to the container upside down)
• Aseptic techniques must be observed
• Label is applied & checked with original
order.
• Empty additive containers are checked to
confirm additives present.
 • Admixture is inspected any color change or
particulate manner.
• Delivered to the floor
• If not infused immediately within 1 hour, it is
stored under refrigeration.
• If refrigerated, must be used within 24 hrs.
• Nurse (checks for label accuracy)
Indications of PN:
• For patients who are not able to ingest food
due to carcinoma or extensive burns.
• For patients who refuse to eat:
➔ Depressed geriatrics
➔ Suffering from anorexia nervosa
➔ Surgical patient who should not be fed
orally
Sterile Products
• Intravenous admixtures
- Resulting solution when one or more sterile
products are added to an IV fluid for
administration.
• Aseptic technique
- Methods used to manipulate sterile products so
that they remain sterile.
• High Efficiency Particulate Air (HEPA)
filter
- Used to decontaminate a room by filtering out
particles greater 0.3 mm in size in the airstream
by 99.97%.
• Negative Pressure Room
- Room at a lower pressure than the adjacent
spaces.
- Net flow of the air is into the room.
• Positive Pressure Room
- Room at a higher pressure than the adjacent
room
- Net flow of the air is out of the room.
• Laminar Air Flow Workbench (LAFW)
- Controlled environment created by HEPA filter to
retain airborne particles & microorganisms.
- Use decreases the chance of contamination
during compounding sterile preparations.
• Isolator
- Controlled environment defined by fixed walls,
floors, and ceiling.
- Transfers of materials into and out of the
environment are separated by barriers such as
gloves, sleeves, and airlocks.
- Inside is a negative pressure.
- Personnel access the inside via the glove ports.
- Used to conduct:
➔ Aseptic filling operations
➔ Sterility testing
➔ Cell culturing
➔ Purification activities
• Clean Room
- Room in which the concentration of airborne
particles is controlled to meet a specified
airborne particulate cleanliness class.
- Microorganisms are monitored.
• Ante area/Anteroom
- Area adjacent to buffer room/clean room.
- Unsterilized products, in-process components,
materials, and containers are handled.
• Closed System Transfer
- Method of transferring one sterile component to
another without contaminating the final
preparation.
- Cold storage condition (Refrigeration) → 2oC to
8oC (36oC to 46oC)
• Buffer Room
- Space designated for compounding sterile
preparations.
• Garb
- Clothing worn by those compounding sterile
preparation.
Accepted garb at LAFW or Biological Safety Cabinet
(BSC
• Clean hair cover
• Face mask
• Long-sleeved with elastic or snaps at the
wrist
• Non-shredding knee-length coat or gown
• Shoe covers
• Sterile gloves
Elements of good Aseptic Technique:
1. Good personal hygiene
• Health
• No eczema, skin rashes
• Free from allergies (sneezing or coughing)
• Wash hand thoroughly or disinfect with
alcohol
2. Put garb properly
3. Put on gloves as final garbing step.
4. Sanitize all internal surfaces of the working area
(except HEPA filter face)
5. Sanitize gloves
6. Replace gloves with new sterile if punctured or
torn.
7. Do not disrupt HEPA-filtered laminar air flow
within critical area.
8. Do not spray or splash disinfectants.
9. Do not introduce packages into buffer room
unless sanitized/sterilized.
10. Pass through doorways, plastic curtains.
Additives
- Injections packaged in ampules or vials.
- Or sterile solids (reconstituted)
Procedure when adding additives:
1. Fresh, sterile, disposable syringe is used for
each additive (single-use only).
2. Before removing measured volume, wipe the
container with disinfectant solution.
Parenteral Incapability
• Physical Incompatibility
- Detected by changes in appearance (color,
formation of precipitate, evolution of gas).
• Chemical Incompatibility
- Decomposition of drug substance.
- Mostly result from hydrolysis, oxidation,
reduction, or complexation.
- Detected only with a suitable analytic method.
 • Therapeutic Incompatibility Products requiring special handling:
- Most difficult to observe. a. Controlled substances (schedule III)
- Results in undesirable antagonistic or synergistic b. Investigational drugs
pharmacological activity. c. Compounded products
- Example: Penicillin antagonizes the effect of d. Repackaged pharmaceuticals
Heparin e. Non-formulary items
f. Medication samples.

Parenteral Incompatibility can be minimized by:

- Using compatibility guides produced by large-
volume parenteral manufacturers:
• On the label
• Reference books
- Selecting another route of administration

Receiving Deliveries
- Name & address
- Cold storage
- Missing, damaged, expiration date, consistency,
seal
- Newly delivered (p.o. receiving copy)
- Not ordered, not received, excess
- signature

Warehousing
- stability protected
• storage requirements (based on USP-NF)
• temperature (monitored daily)
• deliveries (proper location within 24 hours)
• primary label (in front)
• easy accessibility
- arranged alphabetically or by therapeutic
arrangement or by company
- stored off the floor
- monthly inspection
• instability
• clarity
• crystallization
• sedimentation
- assigned personnel (quarterly inspection)
- Separate room for:
• Corrosive
• Highly volatile
• Radioactive
- FEFO, FIFO
- Expiring (highlighted) → “stock rotation” (used of
products before they expire.
- Don’t deliver if:
• Expired
• Recalled
• Improperly stored
- Sound-alike, look-alike, misleading labels
• Color-coded labels
• Not adjacent

Storage Temperature & Humidity

• Freezer → -25oC to -10oC
• Cold (refrigerated) → 2oC to 8oC
• Cool → 8oC to 15oC
• Room temperature → working area
• Controlled Room temp → 20oC to 25oC
• Warm → 30oC to 40oC
• Excessive heat → >40oC