AIR CHANGE RATE (ACH) TEST FOR CLEAN ROOMS
The purpose of the air change rate test is to determine the number of times the air is being exchanged within the cleanroom on an…
Tag: Quality Assurance
POWDER SAMPLING IN PHARMA
INTRODUCTION:- Taking a large amount of powder for analysis is expensive and wasteful, and so it must be reduced. Sampling in its strict sense is…
VALIDATION OF STERILE PACKAGE INTEGRITY
Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…
VALIDATION OF STERILE PACKAGE INTEGRITY 1
Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…
CALCULATION OF LIMIT BASED ON TOXICITY CLEANING VALIDATION
This method of calculation is based on the use of animal toxicity data to determine limits. As mentioned earlier, this method is particularly suited for…
STANDARD DEVIATION PREDICTION INTERVAL (SDPI)
Since uniformity is of primary interest in powder blend validation and because of a concern that a constant sampling error can occur, one approach is…
PERSONNEL TRAINING FOR PHARMACEUTICAL INDUSTRY 3
INTRODUCTION:- The pharmaceutical industry is facing a tremendous changes and challenges nowadays. It has been observed that lack of proficient, talented, capable employees has enforced…
DIFFERENCE BETWEEN FUMIGATION AND FOGGING PROCESS
Fumigation and fogging are two methods commonly used in pharmaceutical companies to control the microbial contamination in controlled area. But now a day’s fumigation of…
TEST METHOD FOR PRESSURE DIFFERENTIALS IN ASEPTIC DISPENSING FACILITIES
Introduction:- The test defined here is an independent check on the accuracy of any continuous monitoring system. It is likely that the test as defined…
TEST METHOD FOR AIR CHANGE RATE (ACR) IN ASEPTIC DISPENSING FACILITIES
Introduction:- Conventional clean rooms operate on the principle that the air supplied to the room is of sufficient quantity to dilute or remove the contamination…
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