PHARMACEUTICAL INDUSTRIAL REPORT ON PRODUCTION OF EYE DROPS AT MENGO HOSPITAL, DEPARTMENT OF PHARMACY

A FIELD REPORT

BY

LWASAMPIJJA BAKER bubakes2000@gmail.com

MARCH 2OO8

PHARMACEUTICAL INDUSTRIAL REPORT ON PRODUCTION OF EYE DROPS AT MENGO HOSPITAL, DEPARTMENT OF PHARMACY

A FIELD REPORT

BY

LWASAMPIJJA BAKER

SUPERVISED BY Mrs. FREDA MUTALYA

……………………………………………………

MARCH, 2OO8

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ACKNOWLEDGEMENTS My most sincere thanks go to my field supervisor Mrs. Freda Mutalya for the great work of guiding us through out the exercise. Equally my appreciations go to other staff Mr.Godfrey Mubuuku, Mr. Andrew Kibumba, Alex Muhumuza and Mrs. Phoebe Babirye for their contribution towards my learning at the facility.

I also like to thank my Principal Tutor Mr. Ojaki Mikloth for laboring and make arrangements and book our stay in this unit. May God bless you.

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TABLE OF CONTENTS

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INTRODUCTION 1.1 BACKGROUND The curriculum of the Pharmacy school indicate clearly that before the end of the course an industrial exposure must be under taken by every one going through out the training. This time around, the industrial attachment was conducted at Mengo Hospital Eye Drops production unit for a period of two three week in the month of March 2008.

Mengo Hospital is a missionary founded Hospital located in Kampala district in Rubaga Division. The hospital has many departments among which the is eye drop production unit was initialize by the Christoffel blinden Mission (CBM) a German based Organization. It’s the above that further established prior to Eye clinic and set the eye drop production unit so as to cater for the medications that related to the eye conditions that were diagnosed at the facility.

The Christoffel blinden Mission based on small scale production initially but this has grown tremendously and now there is production close to three batches i.e. 1500 eye drops can be manufactured a day.

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1.2 OBJECTIVES 1) To acquire Knowledge and practical skills in the production of Eye drops. 2) To carry out exercise on the theoretical knowledge obtained during class lectures. 3) To learn the aspects and activities involved in Field Report writing.

1.3 PURPOSE OF THE INDUSTRIAL ATTACHEMENT The exercise served a purpose of providing more experience in the manufacturing of Eye drops serves to equip me with the necessary knowledge, skills and attitudes relating to manufacturing of Eye drops. The information obtained helped to familiarize me with the condition and equipment including the procedures involved with Eye drops.

1.4 SCOPE OF THE EXERCISE The Field work was conducted between the 10th March, 2008 to the 24th March, 2008 at the Eye production unit of Mengo Hospital Pharmacy department.

1.5 THE PRODUCTION UNIT 1.5.1 Premises: The eye production unit premise is attached to the major pharmacy department and is made up seven rooms namely; • Reception/Office room: This is where all documentation concerning eye drop production is done and kept. Also transactions with clients are made here. • Store room for raw materials.

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Washing room: This is where was of bottles and some equipment is carried out. Also the distillation process takes place here.

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Store room for finished Products. Changing Room: This where full protective gears (Gowns, boots, masks, head caps, gloves) are kept. The dressing process of personnel prior to entering the manufacturing room takes place.

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Production Room: This is where the compounding process takes place Sterilization Room: This is where the sterilization, screening and labelling processes take place.

1.5.2 Equipment: a) Autoclave: For eye drop sterilization b) Electronic balance for weighing ingredients c) Distiller d) Steller Hand Press: For sealing the bottles with the steller caps and pipettes. e) Grid Baskets: These contain the products when in the autoclave. f) Bottle openers: These are used for uncapping the already used bottles. g) LV28 Liquid (Particle) viewer: This is used for Screening finished products. h) Filtration Apparatus: This is composed of; - Funnel: This leads the fluid from the main the main filter. - Sintered Glass Filter:

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- Pressure Gauge and Pump: Increases pressure so as to quicken the filtration process - Tanks (Jerricans)

i) Dispenser device: Measure specific amount of volume to be packed. j) Glassware: This includes the beaker, measuring cylinder and the bottles for packaging the finished products xi. Computer: This is for designing labels and entry/storage of data concerning eye drop production

1.6 PRODUCTION PROCEDURES These involve: 1) Preparing the bottles, caps and pipettes. Already used bottles (vials) are collected and sorted so as to obtain consistent size bottles that suite the volumes to be packed and are then soaked to ease the removal of the label and washing.

Removal of the bottle caps (tops) follows, the uncapped bottles are thoroughly washed and rinsed with cleaned distilled water and then sterilized by autoclaving t 134°C for 3 minutes. Imported steller caps and pipettes are washed and rinsed with freshly prepared and cooled distilled water and kept in a sterile condition, the same applies to the sterilized bottles.

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2) Decontamination of the production room. The room swept, dusted and thoroughly cleaned using jik (Sodium Hypochlorite) and omo detergents. The room is then dried using a mop. This room is kept closed and the air conditioner is turned on. 3) Calculation of the product Formula. Product quantities to be prepared are determined and basing on the manual for eye drop production (WHO Script and CBM) the respective amounts of ingredients to be used in the final production formula is determined. 4) Dressing for the Production room. The personnel to carry out the production process enter the dressing room. In there sterile; Gowns, gloves, head gear, masks and boots, specifically used in the production room are worn. 5) Activities in the Production. The well dressed personnel enter the production room next to the changing room separated by a door, and here, the below take place; ♦ Weighing of ingredients in the working formula using an electronic balance. ♦ The ingredients are dissolved in freshly prepared and cooled distilled water. ♦ The ingredients are thoroughly mixed so as to turn out homogenous. ♦ Filtration of the preparation. ♦ The preparation is filled in the dispensing device.

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♦ The dispensing device under the operation of personnel dispenses a prespecified amount (volume) of the preparation into the sterile bottles. ♦ Bottles containing dispensed preparations are passed to other personnel who cap the steller caps and pipettes onto bottles using a Hand press steller. The above process is continued until all the preparation has been packed in the respective sterile glass bottles. 6) Sterilization. The sealed bottles containing the preparation are packed in grid baskets (maximum of 1500 bottles) which are then placed in the autoclave. The autoclave is closed and set at a temperature of 121°C and the duration interval of 15 minutes is entered. The autoclave is turned on to start the sterilization and once the alarm sound is heard, then its turned off because the sterilization process is over. The pressure is allowed to drop to atmospheric pressure and then the autoclave is opened and the product allowed to cool. 7) Screening. The bottles containing the sterilized preparation are held against theLV28 Liquid (particle) viewer so as to ensure freedom of particulate matter, uniform volume and broken bottles. Some bottles are subjected to sterility testing. 8) Labelling. The sterilized products that have passed the screening test are labeled appropriately 9) Storage The well labeled preparations are stored in suitable conditions awaiting dispensation to the clients.

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1.7 LESSONS LEARNT, CHALLENGES, CONCLUSION AND RECOMMENDATIONS. 1.7.1 Lessons learnt: Equipment like, dispenser head, filtration apparatus, electronic balance, the semiautomated autoclave was practically used. Aseptic techniques were applied for the first time. Interpersonal skills as per relating when in a pharmaceutical production setting were well attained. 1.7.2 Challenges: Autoclave operation was rather different from the one at school. Observing aseptic conditions was a long process. The capacity of the equipment, staff, and structural facility does not meet the high demands, so to meet these demands there is over working of personnel. The time of practice was limited (three weeks) and it wasn’t enough to grasp with in such a short time. 1.7.3 Conclusions: Knowledge and practical skills on the production of eye drops were attained. Report writing skills were obtained.

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1.7.4 Recommendation: The unit should by a paper cutting equipment to ease and shorten the time of cutting labels. The field work time should be made long in order to achieve the objectives of the exercise. The facility should think about employing more Pharmacy Technicians to avoid work load of the only present professionals. The unit should take up a policy of that encourages students to come and practicing at their unit i.e like providing Lunch to the students.

-The end -

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