Guide for Pharmaceutical Manufacturing Industry Research & Development Medical Pharmacy Students FDA updates Guidelines
Custom Search

Friday, February 19, 2010

Time limitations in Aseptic process , Aspects of Sterile Dosage form manufacturing and Aseptic process

21 CFR 211.111 states that “When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.”

When appropriate, time limits must be established for each phase of aseptic processing (CFR 211.111). Time limits should include, for example, the period between the start of bulk product compounding and its sterilization, filtration processes, product exposure while on the processing line, and storage of sterilized equipment, containers and closures. The time limits established for the various production phases should be supported by data. Bioburden and endotoxin load should be assessed when establishing time limits for stages such as the formulation processing stage.

The total time for product filtration should be limited to an established maximum to prevent microorganisms from penetrating the filter. Such a time limit should also prevent a significant increase in upstream bioburden and endotoxin load. Because they can provide a substrate for microbial attachment, maximum use times for those filters used upstream for solution clarification or particle removal should also be established and justified.
Current good manufacturing practice in pharmaceutical industry find it here on this website

==========================================================================
We are getting great response from our readers , we are fluded with requests of  lot of other informations, and topics on pharmaceuticals , like Drug interactions , Incompatibility , FDA guidelines , one of our author who is teaching post graduates in one of best university in USA will be writting over this blog on his topic of intrest , that is Drug interactions .

What is 21 CFR Part 11, US CGMP guidelines requirements of FDA compliance and CFR 21 Part 11.

Truly it will be great to read him on this platform.

We will be writing about Designig of Aseptic process clean rooms for sterile pharmaceutical dosage forms, in next article ,


So stay in touch with our blog .

Over this website you will get complete knowledge about all FDA compliance pharmaceutical manufacturing process and research and development , Pharma Quality assurance, pharmaceutical quality assurance , Pharmaceutical Regulatory Affairs , Sterile Dosage Form and Aseptic process , Pharmaceutical  Pharma good manufacturing practice  and gmp guidelines  ,Aseptic Techniques , Aseptic Manupulations used in Sterile Dosage Form, Injectable Dosage form manufacturing

We encourage you to Signe up to this website and receive our articles by email strait way in to your INBOX as and when we write a new article over this website.

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 a pharmaceutical manufacturers guide

No comments:

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