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.
Ensures Contamination-Free Cleaning and Sterilization
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
- 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.
- 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