The Cleaning performance without cross contamination risks.
The Single use Cleaning-In-Place unit type Bioclean™ is optimally adapted to the Biopharmaceutical industries that demand a combination of highest quality cleaning performance and the elimination of cross contamination risk.
Reproducibility and traceability of the CIP cycles.
The Pierre Guérin design integrates all relevant recommendations of the Biopharma Drug industry norms and standards such as: ASME BPE, GMP, and USP. The complete and qualified automation of these units ensures reliability and traceability of operations, reproducibility of the CIP cycles and precise control of all cleaning parameters.
These systems provide full traceability of the operations through dedicated « Audit-Trail » and Batch Report modules utilizing a SQL database.
Applications
Cleaning In Place of process vessels and piping networks in the Biopharmaceutical industry.
User benefits
- modular and compact concept with pre-mounted, pre-wired and pre-tested units for efficient installation and commissioning – The equipment is available in two versions: type S for non-GMP applications and type G for GMP or GLP validated applications
- self-cleanable systems with full drainability
- control system with intuitive graphical user interface
- micro-PLC – PC based Control technology ensuring robustness and reliability of the system
- software developed from non-proprietary platforms (WinCC-Flex, iFix, InTouch) complying with GMP requirements (21 CFR PART 11 and GAMP 5)
- cleaning data trail, Graph and Batch report modules ensuring full traceability of the CIP cycles
- batch module allowing the User to configure CIP recipes according to Cleaning protocol and equipment
- optional test and documentation package for GLP / GMP environment (FS, HDS, SDS, FAT / SAT Protocols), supporting qualification activities.
Single Use type Cleaning In Place Units Bioclean™