Manufacturers of
sterile pharmaceutical products use aseptic processing for the formulation of
liquids, lyophilized products, FFS, Ophthalmic solutions, PFS products etc.
Aseptic processes are the preferred route for the manufacture of products that
cannot be processed by terminal sterilization.
Aseptic
processing systems are constantly evolving. Controlling and maintaining viable and non-viable particles in the aseptic areas and surrounding environment is a challenge.
There are still multiple grey areas with
respect to activities performed during media fills.
A
few of the lesser understood aspects are:
- Hand sanitization : Frequency, methods
- Changing of gloves : Frequency, methods
- Conversations/discussions in the areas
- Sanitization issues
- Garments/ attire during media fills
- Sampling during interventions
- Personnel issues: Qualification, Training
- Metrics for success and monitoring of the processes
- Electronic surveillance, Access systems: Dos and Donts
People,
their attitudes, knowledge, participation and involvement are key to regulatory
success. Regulatory failure is a result of an issue with one of these keys. This
is revealed by citations in regulatory warning letters. Regulators usually recommend
retraining and re-qualification of the personnel on Aseptic practices and on
compliant behavior.
Experts
can help in devising and in effective implementation of QMS at sterile
manufacturing sites. At Vi’eNnI™ Training and
consulting, we are intensively involved in training and development, aimed at
improvising, personnel practices, behavior and the attitude towards day today
activities. We offer a comprehensive 360⁰solution.
Our workshop
“Heartbeats of™ Media fill” in the month of May 2015 in Indore can be a great
training/learning experience!
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