We have a keen “EYE” for API’s to be used in Ophthalmic Formulations!

DHS-Cycle design and development using different Biological Indicators

APIs used in the pharmaceutical industry are generally non-sterile. It is however essential to use sterile APIs to manufacture a sterile product.

An ophthalmic parenteral manufacturer intended to use a dry powdered steroidal API in the formulation of a sterile product. This steroidal API had a bio-burden of 100 CFU/gm. Options considered although were plenty, we had to narrow our choice to a sterilization process in a DHS. Heat exposure studies at the labs depicted that temperatures < 115⁰C was safe, while there was a risk of product degradation at temperatures >115⁰C.

Our study began in earnest to design a sterilization cycle with trials, to achieve the desired results. A series of trials and constant monitoring of the temperature profile helped us determine a matrix of parameters for sterilization. Trials were conducted using Bacillus atrophaeus as a biological indicator. The exposed BIs were subjected to microbiological evaluation where maximum of a 3-Log reduction was recorded. The sterility test trials were clearly found to be meeting specification, however the minimum Sterility Assurance Level expected for the process was  6 log  !

Sticky situation indeed! The trials although were meeting the sterility test specs in flying colours yet were falling short of the expectations when it came to log reduction. A thorough investigation of the process and the testing strategy was undertaken. An elaborate analysis and an organised ‘detective ‘work led us to the issue! A repeat of the study subsequent to problem identification provided results, those that were amazing yet expected a 6-log reduction finally! Two more trials were conducted to confirm the physical parameters and microbiological tests and the results were bang on!

A happy customer, a robust process, great experiments and yet another feather in our cap. If your process needs similar intervention, our technical spirits aren't doused yet and we await your ‘call’ to get nose-deep into tricky situations.

Reach us to reach you at 080-23506562 or write to us at vienni.india@gmail.com