Monday, February 8, 2010
Importance of aseptic process and aseptic techniques compared to terminaly sterilised pharmaceotical
Nearly all drugs recalled due to nonsterility or lack of sterility assurance in the period spanning 1980-2000 were produced via aseptic processing.
Aseptic process is very important aspect of pharmaceutical products which are required to be sterile and othere method of sterilisation can not be adapted.
Cellular products , which require that the cells remain viable ,are aseptically processed at an earlier stage in the manufacturing process, or in their entirety. Cellular therapy products are an example. All components and excipients for these products are rendered sterile, and release of the final product is contingent on determination of sterility.
There are basic differences between the production of sterile drug products using aseptic processing and production using terminal sterilization.
Terminal sterilization usually involves filling and sealing product containers under high-quality environmental conditions. Products are filled and sealed in this type of environment to minimize the microbial and particulate content of the in-process product and to help ensure that the subsequent sterilization process is successful. In most cases, the product, container, and closure have low bioburden, but they are not sterile. The product in its final container is then subjected to a sterilization process such as heat or irradiation. In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely high-quality environment. Aseptic processing involves more variables than terminal sterilization. Before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes. For example, glass containers are subjected to dry heat sterilisation; rubber closures are subjected to moist heat sterilisation ; and liquid dosage forms are subjected to sterilisation by filtration.
Each of these manufacturing processes requires validation and control.
Each process could introduce an error that ultimately could lead to the distribution of a contaminated product. Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and thus necessitates careful control.
A terminally sterilized drug product, on the other hand, undergoes final sterilization in a sealed container, thus limiting the possibility of error. Sterile drug manufacturers should have a keen awareness of the public health implications of distributing a nonsterile product. Poor CGMP conditions at a pharmaceuticals manufacturing facility can ultimately pose a life-threatening health risk to a patient.
======================================================================
We encourage you to signe up to this website to get automated delivery of articles in to your email inbox , when ever we publish articles over this website related to pharmaceutical manufacturing , pharmaceutical validations , Pharmaceutical good manufacturing practice gmp guidelines , pharmaceutical quality assurance , Pharmaceutical good manufacturing practices, gmp guidelines cgmp , pharmaceutical regulatory affairs , and compliances related articles
This website is most favorite Amongst professionals almost all pharmaceutical companies in USA , Pharmaceutical companies in UK , Pharmaceutical companies in Japan , Canada , UAE , Pharmaceutical companies in India .
This website is pharmaceuticals manufacturers guide .
Latest Pharma Update
USFDA approves first drug Inmazeb to treat Ebola Virus Infection
US FDA approved first drug to treat Ebola Virus Infection (zaire ebolavirus) . So far there was no drug treatment available for Ebola virus ...


You May Also Like
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count Introduction: Clean rooms are classified as per...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
Isolators in pharma manufacturing. What is an Isolator - A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, th...
-
Periodic revalidations in pharmaceutical manufacturing its regulatory and general requirements. Validation in pharmaceutical is not on...

Pharmaceutical Manufacturing Guidelines
Reverse Osmosis Membrane Technology RO Water Purification system
SOP for Mechanical Qualification of Dissolution Apparatus
Standard Operating Procedure How to write a SOP
Sterile dosage form manufacturing facility inspection
Sterility testing in sterile dosage form
Sterility testing of Pharmaceuticals dosage forms
Transdermal Drug Delivery System
Ultraviolet light as antimicrobial disinfectant in water for pharmaceutical use
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
What is a Biosimilar or Interchangeable Biopharmaceutical
What is clinical trial protocol
Common Technical Document(CTD)
What is drug receptors?How drug resistance occur
First pass metabolism of a drug
Lyophilization Freeze Drying advantages and disadvantages of lyophilization
What is a prion, What is Mad Cow Disease
What is protein binding of drug, Why a drug is bound to protein
What is protein binding of drug, Why a drug is bound to protein
Requirements Transdermal drug delivery system
Ophthalmic Preparation |Ophthalmic solution and suspensions
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
GO TO TOP

1 comment:
Can a product containing alcohol be sujected to terminal sterilization? Will the kill efficiency of heat in liquid containing alcohol be different from that of water alone?
Post a Comment