Single use cleaning in place units for biopharma
Eliminate cross-contamination risks in biopharmaceuticals with precision cleaning and unmatched traceability, ensuring your process vessels and piping networks remain pristine and compliant with stringent industry standards.
The Single Use Cleaning In Place Units Bioclean™ from Pierre Guérin is designed for the biopharmaceutical industry, addressing the critical need for effective cleaning without cross-contamination. This CIP unit is ideal for applications in vaccine and monoclonal antibody production, ensuring consistent cleanliness and sterility. The Bioclean™ integrates industry norms such as ASME BPE and GMP, offering traceable and reproducible cleaning cycles facilitated by a complete automation system. Equipped with a micro-PLC and a PC-based control interface, the unit allows for robust, reliable operations with full traceability via Audit-Trail and Batch Report modules. Its compact design allows for easy installation, with pre-mounted, pre-wired configurations to streamline commissioning. Compliance with 21 CFR PART 11 and GAMP 5 standards, coupled with options for GMP or GLP validated applications, ensures it meets stringent industry requirements. This unit includes self-cleanable systems and ensures complete drainability for efficient maintenance. Optional test and documentation packages support GLP/GMP environments, enhancing qualification activities.
Benefits
- Eliminates cross-contamination risks, ensuring product integrity and safety.
- Streamlines installation and commissioning with modular, pre-wired, and pre-tested units.
- Enhances operational efficiency with reproducible CIP cycles and comprehensive traceability.
- Meets strict regulatory standards, supporting compliance with GMP and GLP requirements.
- Facilitates easy maintenance with self-cleanable systems and complete drainability.
- Applications
- Biopharmaceuticals
- End products
- Biopharmaceutical drugs,Gene therapy products,Vaccines,Insulin,Monoclonal antibodies,Biosimilars,Cell culture media,Therapeutic proteins
- Steps before
- Purification,Batch Preparation,Formulation
- Steps after
- Sterilization,Quality Control,Packaging
- Input ingredients
- Output ingredients
- Automation
- Complete and qualified automation
- Cleaning method
- Single Use Cleaning-In-Place
- Compliance
- ASME BPE,GMP,USP
- Traceability
- Full through SQL database
- Control system
- Micro-PLC – PC based Control technology
- Software
- WinCC-Flex,iFix,InTouch
- Batch documentation
- Batch Report modules
- Reproducibility
- High due to qualified automation
- Installation
- Pre-mounted,pre-wired,and pre-tested
- Versions
- Type S and Type G
- Cycle control
- Precise control of all cleaning parameters
- Self-cleanability
- Full drainability
- Optional package
- GLP/GMP test and documentation
- Cycle traceability
- Audit-Trail and Graph modules
- Validation
- GMP or GLP validated applications
- Cleaning method
- CIP
- Batch vs. continuous operation
- Batch
- Automation level
- PLC / PC based
- Traceability
- Full traceability with Audit-Trail
- Installation Method
- Pre-mounted,pre-wired,pre-tested
- Software Platform
- WinCC-Flex,iFix,InTouch
- Cleaning data trail
- Graph and Batch report modules
- CIP recipe configuration
- User configurable according to Cleaning protocol
- Self-cleanable systems
- Full drainability
- Control System Interface
- Intuitive graphical user interface
- Compact footprint
- Yes
- Modular design
- Yes
- Pre-mounted,pre-wired,pre-tested
- Yes
- Self-cleanable systems
- Yes
- Full drainability
- Yes
- Control panel type
- Intuitive graphical user interface (HMI)
- Integration possibilities
- PC-based control technology,SQL database for traceability
- Software platform
- WinCC-Flex,iFix,InTouch
- Modular design
- Pre-mounted,pre-wired,pre-tested
- Self-cleanable systems
- Full drainability
- Batch modules
- Configurable CIP recipes
- Market info
- Pierre Guerin is renowned for manufacturing high-quality, engineered-to-order equipment, particularly for the pharmaceutical and biotechnology industries, specializing in vessels, process systems, and complete turnkey solutions with a strong emphasis on innovation and customer satisfaction.