The foundation of a successful validation project is comprehensive and compliant documentation deliverables. The BTOP (Bosch Turn-Over Package) is a complete record that includes manuals, cut sheets, drawings, design specifications, certificates, instrument lists and software. All documents and software are completed according to the GAMP4 model. Calibrations are traceable to international standards. All activities, including qualification, are performed according to SOP (Standard Operating Procedures) to ensure compliance with international regulatory requirements.

Qualification protocols are written, reviewed and approved at Bosch before FAT begins. IQ work starts as soon as equipment is installed, which is usually during SAT. Validation personnel are at client site for weeks rather than months. This is because they are only present for protocol execution and not for document writing and other support activities. The personnel are trained in the Bosch systems that they qualify; therefore no learning curve is required. If something goes wrong during qualification, the experienced personnel specific to the equipment in question are already on site to resolve the problem. One final report is delivered within 4 weeks of completion of all qualification activities.

Bosch delivers overall savings compared to hiring contractors or performing qualification activities in-house due to:

• Speed of deliverables
• Experience and specificity of validation personnel
• Minimum time required on site

Bosch also provides formal training of operator, maintenance, and supervisory personnel. Training is customer specific to your equipment and needs. A classroom environment is provided with materials for each student. Organized training on the equipment includes setup and startup, changeover, maintenance, adjustment and repair.

Validation of bio-decontamination cycles begins with cycle development. This activity begins during equipment testing and lays the foundation for an efficient cycle.

To learn more about our extensive experience in isolator cycle development and information about the Bosch PharmaLab, please select Cycle Development to the left.