Risk Reduction Solutions for
Pharmaceutical, Life Sciences & Healthcare
From Cell Culture to Vein compliance with
Ecolab Cell and Gene Therapy Solutions
Discover the complete contamination control strategy for your company.
From the R&D phase to the clinical trials phase to the commercial production phase, partner with Ecolab to keep contamination risk under control and your operations on track.
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ALWAYS PLAN WITH REGULATORY COMPLIANCE IN MIND
Cell and Gene Therapy industry provides a unique regulatory challenge to navigate. Compliance very often relies on a case by case risk assessment.
Ideal for Laboratory to GMP Cleanroom
Regulation trends reflected in the recent EU GMP Annex 1 update formally recommend the use of closed systems, such as Isolators. Isolators provide a complete barrier between the process and surrounding environment, offering better in-process contamination control. The use of Isolators should be implemented early in development phase to ease transition from R&D to clinical trials and commercial manufacturing.
The development of novel Cell & Gene therapies such as CAR T-Cells, mRNA or stem cell therapy requires extended Research and Development activity before starting clinical trials. The Bioquell Qube is a standard, off-the-shelf isolator which provides a grade A/ISO 5 working environment without the need for complex integration into a building. This means no construction work, removal of cleanroom panels, no HVAC connections needed, and no additional electrical installations are needed. Due to its unique polyproylene construction, the Bioquell Qube can be delivered, installed and validated in as little as 16 weeks.
ECOLAB’S BIOQUELL QUBE ISOLATOR, THE IDEAL SOLUTION
“*EPA Registration Number: 72372-1-86703”
ADVANTAGES OF THE BIOQUELL QUBE ISOLATOR
SPEED
- Quick implementation and short lead time
- 6-log sporicidal kill on exposed surfaces in the isolator
- Delivery, installation, and validation in as little as 16 weeks
CONSISTENCY
- Provides Grade A / ISO 5 environment via HEPA filters and powered downflow to meet Annex 1 guidance
- Validated, automated bio-decontamination cycle with repeatable results
COST
- Cost effective due to its unique polypropylene construction
FLEXIBILITY & SCALABILITY
- Ability to expand the working space as your operations grow
COMPLIANCE
- Helps provide product consistency to assist in meeting compliance standards from regulatory bodies around the world
- EPA approved, Annex 1 compliant, and BPR approved*
*BPR, Regulation (EU) 528/2012); EPA Registration Number: 72372-1-86703
SEE THE SAVINGS
Download our case studies
Showcasing the Bioquell Qube’s impact in cell and gene therapy.
Case Study 1: See how this company saved hundreds of hours in productivity and cut energy costs.
Case Study 2: Discover how a company increased profitability while reducing batch failure and more.
VIEW THE CONFIGURATIONS
EU GMP Annex 1 recommends that an appropriate Contamination Control Strategy (CCS) is implemented to ensure compliance and patient safety. Isolator systems can create a closed process that helps mitigate the risk of contamination during all critical aseptic operations, from genetic engineering to fill/finish.
The Bioquell Qubes modularity supports your operations, from small batch production to processes requiring multiple human interactions to regulatory and quality control needs.
Find the right setup for your process with our configuration sheet.
COMPREHENSIVE SOLUTIONS FOR YOUR CLEANING AND DISINFECTION NEEDS
Cleaning and Disinfection Solutions
- Bio-decontamination equipment for rooms, equipment, pass-throughs, material airlocks and more
- Manual cleaning and disinfection
Integrated Bio-decontamination Isolators
- Bio-decontamination service option for a fully managed, scalable response for your scheduled or emergency response needs
- Bioquell hydrogen peroxide vapor bio-decontaminations connected to existing isolators and equipment
Validation Support
- Support to validate your Contamination Control Strategy according to regulation and avoid findings during audits
MORE THAN JUST CLEANING AND DISINFECTION EQUIPMENT AND SUPPLIES
- Find operational efficiencies
- Increase the total value of your process by sticking with GMP and other regulatory guidance
- Create compliance-based SOPs early for faster approvals
- Discover energy and other cost savings
- Ensure your cleaning and disinfection products are compatible with your operations
- Focus on building lifesaving products, while we handle contamination control
Learn more about Bioquell’s technology here or contact us below
Contact Us
To learn more about how Bioquell can fit your solution, please contact us.
The Americas
Ecolab Inc
702 Electronic Dr. Suite 200
Horsham, PA 19044
+1 215 682 0225
bioquellusorders@ecolab.com
