When developing a liquid injectable product, the R&D team in a Pharma organization needs to carry out certain compatibility studies.
These studies are conducted to check whether there's any impact of contact materials used in manufacturing process on product quality.
I've summarised generally conducted compatibility studies along with the procedure and test parameters in here. Some procedures and parameters may vary from company to company.
1. Manufacturing Tank Compatibility
- Hold bulk solution in tank for 72 hours.
- Test for Desciption, pH, Assay & RS
2. Tubing Compatibility
- Circulate the bulk solution for 12 hours through peristaltic pump.
- Test for Desciption, pH, Assay & RS
3. Filter Compatibility
- Immerse the filter into unfiltered in unfiltered bulk.
- Test for Desciption, pH, Assay, RS, Sterility, Particulate matter & BET
4. Rubber Stopper Compatibility
- Charge the finished product in stability for 6 month at accelerated condition.
- Test for Desciption, pH, Assay & RS
5. Glass Compatibility
- Charge the finished product in stability for 6 month at accelerated condition.
- Test for pH & Silicon Content
Read also: CPP & CQA in Sterile Product Manufacturing
Resource Person: Sunil Tekwani
