Microbiology

BET and sterility validation of microbiology  BET and sterility validation of microbiology consists of the following:- Protocol No. for BET and sterility validation should be written in format PR/MV/AA/ BB/CC/DD and report No. should be written in format RP/MV/AA/ CC/DD . PR refers to protocol, RP refers to Report, MV …

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated …

Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production cycle need to estabilished. A sterility assurance of 10 or -6 better should be demonstrated for any terminal sterilization process. The level of sterility assurance should be demonstrated for all parts of the drug product …

Microbiological Monitoring of the Environment The microbiological monitoring program shall be performed during routine production and media fills and procedure for microbiological monitoring program are clearly defined in SOP. Microbiological monitoring – frequency of monitoring, type of monitoring, sites monitored, alert and action level specifications, and clearly defined procedure for …

 Functioning, cleaning and maintenance of Static Pass Box. Objective: To lay down the method for the ordinary operation, cleansing and preservation of the Static Pass Box (SPB). Scope: This SOP is relevant to the Static Pass Box present inside the microbiology lab. Responsibility: Chemist or above of QC laboratory. Head …

STERILITY ASSURANCE 〈1211〉 INTRODUCTION Definition of sterility – An item is deemed sterile only when it contains no viable microorganisms. However, this textual definition cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing. Sterility cannot be demonstrated without the destructive testing of every sterile unit. …

Functioning, cleansing and maintenance of Dynamic Pass Box Objective: To lay down the method for the habitual operation, cleansing and renovation of the Dynamic Pass Box (DPB). Scope: This SOP is relevant to the Dynamic Pass Box present inside the microbiology lab Responsibility: Chemist or above of QC laboratory. Head …

Functioning, cleansing, and maintenance of Sterile Garment Cabinet Objective: To lay down the system for the ordinary operation, cleansing and protection of the Sterile Garment Cabinet (SGC). Scope: This SOP is relevant operation cleansing and protection of the Sterile Garment Cabinet present in the microbiology lab. Responsibility: Chemist or above …

SOP on Functioning, Calibration, Cleaning, and Maintenance of LAF Objective: Technique for functioning, Calibration, Cleaning, and Maintenance of LAF. Scope: This SOP is relevant for the Operation, Calibration, Cleaning, and Maintenance of LAF in the Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head …

Effectiveness of Antimicrobial Preservatives in Pharma industry The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product. The primary purpose of adding antimicrobial preservatives in Pharma industry to …