Cycle Development Of Pharmaceutical Isolators

Establishing a reproducible, consistent bio-decontamination cycle is the key to optimal isolator function.

Establishing a reproducible, consistent bio-decontamination cycle is the key to optimal isolator function. Cycle development is a required activity for all isolator systems, as each system will perform differently based on a number of physical characteristics.

Bosch’s cycle development activities include:

• Identification and full evaluation of all ‘worst case’ and process critical positions within the chamber
• Use of CI’s (chemical indicators) to verify the homogeneity of peroxide distribution
• Direct, real time peroxide measurements gathered during testing
• Use of BI’s (biological indicators) under challenging conditions to determine the exact threshold of microbial kill
• A complete D-value assessment for characterization of the entire system

Fully defining the cycle parameters will ensure full microbiological kill using an efficient cycle. Our testing yields a set of parameters, which assure kill in all ‘worst case’ and process critical positions. Three consecutive runs of the optimized cycle are then performed to demonstrate process stability.

Strong cycle development expertise is what separates Bosch from other isolator manufacturers. The Bosch team includes Microbiologists, Pharmacologists, Pharmacists, Food and Pharmaceutical Engineers. The team has extensive hands-on experience with all major bio-decontamination systems, including the Bosch SafeVAP system.

The Bosch PharmaLab was established jointly with Pharmadule as a complete support and testing laboratory. The 120 m² lab is an ISO 8 classified cleanroom space that includes an 8 m³ production-type isolator along with a support laboratory. The purpose of the PharmaLab includes:

• Development lab for new equipment and processes
• Isolation Technology Center for customers
• GMP and isolator training
• Cleaning validation support lab
• Platform for new validation services