Handle Microbial Cultures in Separate Room : Pharmaceutical Guidelines

Editable Pharmaceutical Documents in MS-Word Format

View

8

Handle Microbial Cultures in Separate Room

Contamination of sample with the positive control and cultures can be prevented using separate area for culture handling.
Separate laminar air flow unit in a separate room for the handling of microbial cultures is a new trend in pharmaceuticals nowadays. Before some time all microbiological activities were done under same laminar airflow bench including positive cultures, sub-culturing, sample preparation and analysis. But now it is changing to have a separate area for culture handling and sample analysis.

Layout
The idea behind the separate area for these activities is the possibilities of contamination of the positive cultures in the samples causing the inaccurate results. Both of the rooms should not be separated only by a single door

These may open in a common corridor but the room dedicated to culture handing should have less pressure than the corridor. It is done to prevent the entrance of the contamination from culture handling room to the corridor and further possibility to enter in sample analysis room.


No regulatory agency has this concept in written but it has been seen many times that Food & Drug Administration (US-FDA) and Medicines & Healthcare products Regulatory Agency (MHRA) auditors ask to have the separate room and laminar air flow for sub-culturing and preparation of positive controls.


Positive controls should also be transferred in incubator room through separate passbox. Pathogen and other cultures should not be opened or used in other areas of the laboratory except dedicated culture handling area, washing and decontamination area.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

No comments: Read Comment Policy ▼

Post a Comment


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters

Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg

Discussion - Latest Topics

Show All ❭❭Pharmaguideline Forum



GET APP FOR NEWS UPDATES

Pharmaceutical Updates




✔ Worldwide Regulatory Updates
✔ Pharmaceutical News Updates
✔ Interview Questions and Answers
✔ All Guidelines in One Place

Install


Recent Posts