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1.
1.1 Introduction
The company was established in 1998.The plant is presently engaged in the manufacture of small volume parenterals (Ampoules and Vials).
Nandani Medical Laboratories Pvt. Ltd. is situated near bypass Kanadia road, Bicholi
Hapsi, Indore. It is headed by Mr. Arun Kharia and technical director is Mr. Anil Kharia. It is a subdivision of Modern Laboratories Pvt. Ltd. It deals with various pharmaceutical products like injections, dry injections, ampoules, vials etc. It is engaged in the manufacture of various dosage forms for last 22 years.
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1.2
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1.3
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Organogram
Managing Director Mr. Arun Kharia
Technical Director Mr. Anil Kharia Marketing Mr. T.C. Barjatya Administration Mr. M.L. Sharma
QC Manager
QA Manager
Manager Accounts
Production Chemist
QC Executive
Store Incharge
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Sterilized Water Boil to 800C & mix preservatives (Methyl paraben + Propyl paraben) & maintain at 60-700C Dissolve the active ingredient Screen through Prefilter (0.2m) & post filter (0.25m) Store in storage room and send to filling room by use of positive pressure (N2 gas used) Removal of any unwanted substance by suction & filling is followed by displacement of air by N2 gas. Sealing Labeling Testing for appropriate quantity in each ampoule or vial and also testing for any particle. Packaging Quality Control
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3. Manufacturing sections
3.1 Water Handling section Water is the essential part of the human being as well as of industries. Water is used as a solvent and also for the washing of ampoules and vials. In the industries borwell water is used. This water is treated as follows :
1) Softening of water : The process of decreasing the hardness of water is called as
softening. It involves decreasing the concentration of calcium magnesium salt in water. It is done by ion exchange process. 2) Demineralization : In this process softened water is demineralized. In the process minerals are removed from water. 3) Distillation : Demineralized water is then distilled by multiprocessing distillation unit in the industry. The conductivity of distilled water is zero.
3.2 Air Handling Section In the industry air is also purified with the help of different range of filters. Atmospheric air is sucked and passed through different range of filters (10, 20, 40, 50 & 100), which are arranged in sequence. After that the air is passed through HEPA Filters which have ability to filter about the range from 0.3-0.5 particles very easily. This purified air is than supplied to the area where product is handled by stainless steel pipe lines.
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3.3 Sterilization Process 1) Steam Sterilization 2) Dry Heat Sterilization 3) Membrane Filtration
This process is done by using an apparatus called Autoclave. In this process sterilization is done by moist heat. Moist heat is more effective than dry heat for thermal sterilization. With the help of this process, ampoules, rubber gloves, rubber closures, etc. can be sterilize. This process is done at temperature about 121C. 3.3.2 Dry Heat Sterilization
Substances that resist degradation at temperatures above approximately 140C (284F) may be rendered sterile by means of dry heat. Two hours exposure to a temperature of 180C (356F) or 45 min at 260C (500F) normally can be expected to kill spores as well as vegetative forms of all microorganisms. 3.3.3 Membrane Filtration
Filtration may be used for the removal of particles, including microorganisms from solution and gases without the application of heat. Membrane filters function primarily by sieving, or by screening particles from a solution or gas, thus retaining them on the filter surface. In the industries it is used to filter the solution.
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4. Manufacturing Process
4.1 Washing, Drying & Sterilization Of Vials & Ampoules: The vials & ampoules are first washed by workers and then are washed again & dried simultaneously by automated machine. The washed and dried ampoules & vials are sterilized by either autoclaving or DHS.
4.2 Preparation of the Bacteriostatic water for injection & Formulation of the Drug: Water for injection is heated to about 800C and preservatives i.e. methyl & Propyl paraben is dissolved in it. It is then passed through a pre filter (0.2m dia) and a post filter (0.25m dia) and stored in storage tanks which are aseptically maintained. The drug is then mixed aseptically in it and is then pumped in filling area by use of N2 gas (+ve pressure).
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4.3 Filling & Sealing: By automated process, the machine fills and seal about 6000 ampoules and 5000 vials per hour. The drug is filled by automated process in 3 steps. The automated machine has 3 nozzles.
The first nozzle sucks any unwanted leftover material in the vial or ampoule. The second nozzle fills in the drug of measured quantity. The third nozzle displaces any air by N2 gas to prevent oxidation.
Immediately ampoules are sealed by heating the tip and pulling it of while vials are closed by rubber stoppers and sealed by aluminium backing.
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4.4 Labeling: Labeling of vials and ampoules is done by automated labeling machine.
4.5 Particle Testing: Each vial and ampoule is tested for presence of any type of particle. Vials and ampoules are visualized against a white and black background for any particles. Ampoules are also tested for particles bay an automated particle testing machine which holds 6 ampoules at a time. A bright background is there for visualization and a convex lens is provide which magnifies the ampoules. The ampoules are shaken automatically and detected for particles. Any faulty ampoules are rejected automatically.
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5. Packaging:
Vials and ampoules are packed individually. Ampoules are also blister packed. 5.1 Process of Blister Packing: The die is connected with vacuum pump. The PVC softens on the application of heat and the softened PVC is sucked by vacuum to form blisters. The blisters are then immediately cooled. The ampoules are filled automatically and pass through the sealing rollers where PVC and the supporting film is sealed together. An automatic cutter separates the strips.
Fig 12:- Blister packing of ampoules. MODERN INSTITUTE OF PHARMACEUTICAL SCIENCES, INDORE
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6. Quality Control: Samples of products are sent for testing which includes:a) Accelerated Studies, b) Sterility Testing, c) Bacterial Endotoxin Test, d) Leaker Test, etc.
7. Quality Control & Quality Assurance: The quality control & quality assurance is taken out simultaneously. The quality control department of Nandani Medical Laboratories responsible for: To manufacture products of best quality. To make quality policy understandable and implemental at all levels. To make all employees aware of quality programme of the company and educate them through training in current GMP and quality improvement techniques. Strive to attain quality improvement in companys total performance as a continuous process.
Fig 13:- Functions of Quality MODERN INSTITUTE OF PHARMACEUTICAL SCIENCES, INDORE Assurance
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1) Accelerated Study Apparatus. 2) Autoclave. 3) Dry Heat Sterilizer (D.H.S.). 4) Incubator (small). 5) Vacuum Oven (to find out L.O.D.) 6) Magnetic Mixer. 7) Conductivity Meter. 8) pH Meter. 9) U.V. Spectrophotometer. 10) Polarimeter. 11) Incubator (large). 12) Electronic Balance. 13) Water Bath. 14) Karl Fischer Titrator. 15) Magnetic Stirrer. 16) Friability Apparatus. 17) Hot Plate. 18) H.P.L.C. 19) TLC Detection Chamber (UV)
All instruments are calibrated every month by the team members of the Q.C. Department & are calibrated once a year by some specialized & qualified person from outside.
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Autoclave
Vacuum oven
Conductivity Meter
HPLC
Hot plate
MODERN INSTITUTE OF PHARMACEUTICAL SCIENCES, INDORE pH Meter Karl Fisher titration apparatus
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N-clox Injection Diclofenac injection I.P Ampicillin injection I.P Analgin Injection (NFI) Ciprofloxacin Injection Chloroquine phos. Injection Dexamethasone phos. injection
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11. Conclusion In conclusion, there were many things that I have experience and learned during the one month of my Industrial Training at Nandani Laboratory, Indore. The whole training period was very interesting, instructive and challenging. Through this training I was able to gain new insights and more comprehensive understanding about the real industry working condition and practice. During the training I have learned about the Sterilization processes and about the testing of sterile products. I under stand the importance of water purification method as well as working of air handling unit system. This also has provided me the opportunities to develop and improve my analytical and functional skills. All of this valuable experience and knowledge that I have gained were not only acquired through the direct involvement in task given but also through other aspect of the training such as work observation, working environment, observational skills and other documentation and regulatory requirements. From what I have undergone, I am hundred percent agree that the industrial training program have achieve its entire primary objective. Its also the best ways to prepare student in facing the real working life. As a result of the program now I am more confident to enter the employment world and build my future career.
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