SWAB STICK FOR CYTOTOXIC DRUG CLEANING VALIDATION

CLEANING VALIDATION OF CYTOTOXIC DRUG
As per current all regulatory authority it is a mandatory requirement for cleaning validation for all cytotoxic drug product special is direct contact part of the manufacturing site. Based on the critical swab location and other factor cleaning validation was carried for each product based on the following issue
1. PDA values (Must be approved by certified toxicologist)
2. Daily dose of the Product
3. API used in a single batch
Another factor like surface area and criticality of sample is the secondary part of cleaning validation. Before selecting the swab location, proper justification must be required, which must be present in CBMP and CLV protocol.
In this total cleaning validation process, Swab plays a big role because if the swab stick gives an unusual pick or Shedd any particle, then total CLV will be failed and it will give an inconclusive result. To overcome this issue, most of the leading pharmaceutical companies now use TX716 or Alpha® TX715, a brand product of leading cleanroom supply company Texwipe USA.

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