Monday, February 17, 2014

Start Clean Room Qualification

Clean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a days available with well define limits of viable and non viable for different grades (A,B,C,D). But practically it is initially very difficult to build up the practice in a new green field facility, where you have to establish the system in a proper way. Since cleaning is the major issue, Qualification study was designed,Standard Operating Procedure are prepared and personnel are trained accordingly. During study Clean rooms are observed with few parameters under At rest and as well as In Operation condition. 

Monday, February 10, 2014


1    Get the facility design right from the start
2    Validate processes
3    Write good procedures and follow them
4    Identify who does what
5    Keep good records
6    Train and develop staff
7    Practice good hygiene
8    Maintain facilities and equipment
9    Build quality into the whole product lifecycle
10  Perform self audits

Wednesday, February 5, 2014

Water System Design In Pharmaceutical Industry In Sterile Injectable Facility

1. PW Generation, Storage and Distribution System
2. WFI Generation, Storage and Distribution System
3. PSG Generation and Distribution System

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