One of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before aseptic activity starts, allowing for the exposed interior surfaces within to be bio-decontaminated, […]
“Fixing problem “is the main activity at pharmaceutical industry now a day. Rather than manufacturing medicine, we are focusing on the failure investigations, root cause identification, CA-PA implementation & effectiveness verification. When a facility or a product is designed, the risk based approach not followed. Maximum problems observed during tech transfer from R&D to commercial manufacturing. […]
The most important word in the pharmaceutical industry. Usually number of audit concluded based on the “What” and How? Few important examples are quoted below, What is the equipment requalification frequency? What is the HEPA replace frequency? What is the calibration frequency? Once you provide the reply of their next question will be, how you […]
Understanding and analysis of Equilibration Time will tell, how your cycle is consistent. Recently an article in PDA journal (1) was published to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the reduction of the equilibration time. Based on the all demonstrated study in the […]
