Aseptic Processing ( SPS ; SOAU )

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A Seminar on Aseptic Processing Operation:

A Seminar on Aseptic Processing Operation PRASANDEEP BISWAL REGD NO. 1161651012 M.PHARM, 2 nd sem DATE : 29 . 03. 2012 SPS, S “O” A UNIVERSITY M.PHARM SEMINAR SUB: A.P.T


Contents Introduction Contamination Control Microbiological Environmental Monitoring Microbiological Testing of Air Microbiological Testing of Water Evaluation of Aseptic Operations References

Introduction :

Introduction Aseptic - Free from microorganisms that produce septic  or septic disease. Sterile Manufacturing Processes are of Two types Terminal Sterilization Aseptic Processing

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Terminal Sterilization Sterilization done for the final product Product, Container, Closures will have the low Bio-Burden but Sterility is not guaranteed. Drug Product Container Closure Sterilization Process Sterile Drug Product

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Aseptic Processing Sterile products, which cannot receive a post filling lethal treatment because the product, container cannot withstand terminal sterilization treatments. Aseptic processing of the drug product, container, and closure are subjected to sterilization processes separately and then brought together in clean room environment to create the finished product.

Aseptic Processing :

Aseptic Processing Sterilization Sterilization Sterilization Sterile Closure Sterile Drug Product Aseptic Processing Sterile Container Sterile Final Product

Clean Room Classification as per USFDA:

Clean Room Classification as per USFDA

Sources of Contamination:

Sources of Contamination Personnel borne Contaminants Airborne contaminants Human error Non–routine operations during aseptic process Mechanical failure Surface contaminants Failure of HEPA filter Inadequate or improper sterilization

Contamination Control:

Contamination Control Personnel borne Contaminants Minimum number of personnel in clean areas Should not enter clean rooms if ill or with open wounds No shedding of particles, Head gear, Goggles, over gowning, boots and gloves are to be worn. Movement Should be slow and controlled No watches, jewellery and cosmetics

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Airborne Contamination Control Maintenance of a hygienic laboratory Frequent disinfection of floors and surfaces Minimizing the traffic in and out of the area Use of laminar air flow Units

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Use of LAFS LAFS use 0.2 µ HEPA Filters HEPA Filter was designed and installed in 1940’s Minimum particle collection efficiency: 99.97% for 0.3µm diameter particles. Filter made of pleated borosilicate glass To achieve class 100 conditions HEPA filters are required LAFS are of 2 types Horizontal LAFS Vertical LAFS

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GENERALLY Use of Sticky Mats Use of Air Locks for every Clean Room Use of Air Curtains at the plant entry

Environmental Monitoring :

Environmental Monitoring Particulate Matter Particle Counter Differential Pressure Positive pressure differential of 10-15 Pascal should be maintained between adjacent rooms of different classification (with door closed). Most critical area should have the highest pressure Air Changes and Air flow patterns Air flow over critical areas should be uni -directional Temperature and Relative Humidity Ambient Temperature and RH.

Microbiological Testing of Air:

Microbiological Testing of Air Two types of Microbiological Air testing Methods Sedimentation method Impaction method 1. Sedimentation method : The principle involved is Gravitational fallout in a given time on a given area. Irregularities in counts due to wild air currents, physical movement of personnel etc.

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2. Impaction Method Different types of air samplers use this principle The particles in air Impact onto the medium plates by the application of Electrical or mechanical forces. Slit Samplers Sieve Samplers Centrifugal Samplers

Microbiological Testing of Water:

Microbiological Testing of Water Membrane filtration technique Standard Plate Count technique Most Probable Number Test BOD Test

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1.Membrane Filter Technique 100 ml water sample is passed through Membrane filter Filter pad is then transferred to a bacteriological growth medium Bacteria trapped in the filter grow on the medium and form colonies when incubated. By counting the colonies, an estimate can be made of the number of bacteria in the original 100-ml sample.

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2.Standard Plate Count Technique Samples of water are diluted in jars containing 99-ml sterile water Samples are placed in Petri dishes with nutrient agar medium. After incubation, the colony count is taken and multiplied by the dilution factor to obtain the total number of bacteria per ml of sample.

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3. Most Probable Number Test (MPN TEST) Tubes of lactose broth are inoculated with water samples measuring 10 ml, 1 ml, and 0.1 ml. During incubation, coliform organisms produce gas Depending upon which tubes from which water samples display gas, an MPN table is consulted and a statistical range of the number of coliform bacteria is determined. The MPN test is easy to perform but is not exact as standard plate count method.

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4. The Biochemical Oxygen Demand Test : The BOD is the amount of oxygen required by the microorganisms during their growth. The BOD test is begin by noting the oxygen concentration in a sample of water before incubation The water is then incubated in an air-tight, stoppered bottle for a period of about five days at a temperature between 5° and 20°C The oxygen concentration in the water is then noted again, and the difference in the dissolved oxygen is the BOD A higher BOD indicates presence of a higher amount of organic matter

Evaluation of aseptic operations:

Evaluation of aseptic operations Media Fill Tests(MFT): Most useful methods for evaluating SAL of an aseptic filling operation is Media Fill Tests(MFT). MFT is the exact simulation of an aseptic process except that a microbiologic growth medium is substituted for the active ingredients in a sterile product. MFT is used to identify the potential weakness in an aseptic processing operation that might contribute to microbiologic contamination of the drug product. Minimum of 3 MFTs should be performed for initial validation of Aseptic Processing Operations.

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Media and Incubation Conditions for MFT : Ideal Medium for MFT Soyabean Casein Digest Medium (SCD) also known as Triptic Soya Broth (TSB). Commercially available TSB is Tripticase™ Fluid Thioglycollate Medium (FTM) Incubation Conditions 14 days at ambient temperature (20 ° -25° C)

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Practical limitations of Media fill Tests do not permit validation of SAL greater than 10 -4 For example Filled units (Vials) SAL 30,000 10 -4 3,00000 10 -5 30,00000 10 -6

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We can however estimate the Sterility greater than 10 -4 by using mathematical model of “Whyte”. Contamination Rate = 0.0032 d 2 A n t Where d – Equivalent particle Diameter C – Concentration of Airborne Microorganism/cm 3 . A n – Neck area opening of the container in cm 2 . t – Time of Container Opening is exposed to Environment According to “Whyte” the microbiologic Contamination of Aseptic Processing Operation is a function of Concentration of Airborne microorganism (C), The neck area opening of the container being Fixed ( A n ) and the length of time of the Container remains open(T).


References Second edition, prof . C. P. Baveja , Text book of Microbiology : Arya publications – Reprint 2007 : page 615-620 Seventh edition, Ananthanarayan and Paniker’s , Text book of Microbiology, Edited by CKJ Paniker , published by orient longman PVT Ltd 2005 : page 604-609. Guidance for industry ; Sterile Drug products produced by aseptic processing - cGMP Sep 2004. WHO GMP guidelines – Technical Report series 937 FDA Guidance for Industry: sterile drug products produced by aseptic processing cGMP 2002.

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ThAnk You SPS, s “O” A university

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