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Aseptic Process Technology

1. Aseptic processing is a method used to package sterile products like pharmaceuticals and foods while maintaining sterility. It involves packaging sterile items in a sterile container in a sterile environment. 2. There are guidelines for aseptic processing design, personnel flow, air filtration, material selection, and sanitization to ensure sterility is maintained. 3. Quality control tests are conducted including environmental monitoring, media fills, sterility testing, and stability testing to confirm the process is properly maintaining sterility.

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Himanshu Shahu
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783 views

Aseptic Process Technology

1. Aseptic processing is a method used to package sterile products like pharmaceuticals and foods while maintaining sterility. It involves packaging sterile items in a sterile container in a sterile environment. 2. There are guidelines for aseptic processing design, personnel flow, air filtration, material selection, and sanitization to ensure sterility is maintained. 3. Quality control tests are conducted including environmental monitoring, media fills, sterility testing, and stability testing to confirm the process is properly maintaining sterility.

Uploaded by

Himanshu Shahu
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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ASEPTIC PROCESS
TECHNOLOGY
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Aseptic processing is the process by which a sterile (aseptic)


product (typically food or pharmaceutical) is packaged in a
sterile container in a way that maintains sterility.
 such as some pharmaceutical products must be sterile
injections, ophthalmic preparations, solutions, suspension,
emulsions, ointment haemodialysis solutions.
 Two categories of sterile products – those that can be sterilized
in final container (terminally sterilized) – those that cannot be
terminally sterilized and must be aseptically prepared.
 This guidance pertains to CGMP regulation ( 21CFR parts
210 and 211.
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 Design
 Zoning, Pressure, Temperature
 Relative Humidity, Personnel and Material Flow
 Air Filtration

 Material of Construction
 Sanitization – Component
 Preparation/Sterilization

Product Formulation, Filtration, Filling, Lyophilization, Capping


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Gowning Qualification.

Environmental and Personnel Monitoring, Aseptic Filling


Simulations (Media Fills).

Sterility Testing, Particulate Testing, Container Closure


Integrity Testing, Other Final Product/Release Testing,
Stability Testing.

Media Fill Records, Production Batch Records, EM Trend


Data, Release Testing Batch Records, Investigation.
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 Monitoring at Aseptic Manufacturing


 Clean Rooms
 Room Classification
 Risk of Contamination
 Particle Monitoring
 Microbiological Monitoring
 Personnel, Training and Entry to Clean Rooms
 Cleaning and Sanitization
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 Evaluation, Limits and Trends


 Sampling Sites
 Measures in Case of Exceeding Limits
 Documentation
 Sterilization Procedures
 Cleaning and Sterilization of Equipment
 Necessity of Environmental Controls
 Environmental Controls Versus Normal
Environmental Control
 Site Locations
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Dosage forms are pharmaceutical drug products in the form in


which they are marketed for use, with a specific mixture
of active ingredients and inactive components (excipients), in
a particular configuration (such as a capsule shell, for example),
and apportioned into a particular dose.
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(A)Parenteral preparations.
(I) Small volume parenteral (volume less than 100 ml).
(ii)Large volume parenteral (volume 100ml or more than 100ml).
(B)Ophthalmic preparations.
1)Ointments
2) Suspension
3) Emulsion
4) Eye drop
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Parenteral preparations are defined as solutions,


suspensions, emulsions for injection or infusion
They are sterile preparations intended to be
administrated directly into the systemic circulation
in human or animal body.
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Content(Formulations):
a. Therapeutic Agents : API
b. Vehicle(Solvent): Aq., Water miscible , Non-
Aq.
c. Additives: Tonicity adjacent Preservative,
Antimicrobial etc.
2. Container : Glass, Plastic(Thermoplastic)
3. Closure: Rubber ( Elastomer, Natural)
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 Indian pharmacopeia 2014. page no 956-957, 59,


258, 933.
 Good manufacturing practices for sterile
pharmaceutical product in WHO expert committee
on specification of pharmaceutical preparation
WHO 2002
 Guideline for industry sterile drug product
produced by aseptic processing current good
manufacturing practice 2004
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