RTU GMP Flex Space
Panthera’s ready-to-use GMP flex spaces are offered as a service-based solution for pharmaceutical and biotechnology companies needing immediate access to qualified cleanroom environments, without the burden of long facility buildouts. These GMP suites are maintained and operated by Panthera, ensuring consistent compliance with regulatory standards.
Each space is designed and qualified to control critical environmental parameters, including temperature, humidity, differential pressure and air quality, ensuring product safety and integrity. The suites are fully equipped with essential infrastructure such as HVAC, utilities and support facilities. Each suite has access to a common corridor to accommodate entry/exit of large equipment.
WHAT IS A READY-TO-USE CLEANROOM?
A ready-to-use cleanroom is a fully operational, compliant, and validated environment designed for immediate use upon delivery. It comes pre-equipped with all necessary features, including HEPA filtration, temperature, humidity and differential pressure (DP) control, and industry-specific amenities to meet regulatory standards.
WHO ARE THESE CLEANROOMS DESIGNED FOR?
These cleanrooms are ideal for pharmaceutical and biotech companies, contract research organizations (CROs), and clinical trial manufacturers looking for rapid, flexible cleanroom solutions without the lengthy buildout process.
WHAT EQUIPMENT AND FURNITURE ARE INCLUDED WITH THE CLEANROOMS?
- BioSafety cabinets, stainless steel tables, carts, cabinets and racks
- Gowning stations and personnel / equipment pass-throughs
- Environmental monitoring systems for real-time compliance tracking
WHERE IS THE PRODUCT STORED WITHIN THE CLEANROOMS?
The cleanrooms will be equipped with SS cabinets for storage of in-process materials. For larger storage needs, we can offer adjacent access and environmentally controlled areas as required by the product specifications. Access to these products is restricted to PBS personnel only.
WHAT CLASS OR CERTIFICATION DO THESE CLEANROOMS MEET?
Our cleanrooms meet ISO Class 7 standards, suitable for most GMP manufacturing applications. Higher classifications can be achieved using BSCs, isolators, hoods, etc.
HOW LONG DOES IT TAKE TO SET UP A CLEANROOM ON-SITE?
Our cleanrooms are pre-built and can be operational in as little as two weeks, depending on the complexity of customer requirements
CAN THE CLEANROOMS BE CONFIGURED TO FIT SPECIFIC CLIENT NEEDS?
Yes, the cleanrooms are modular and can be customized for size, layout, and additional features, such as specific environmental controls, additional utilities, or enhanced monitoring systems.
WHAT SUPPORT SERVICES ARE AVAILABLE AFTER INSTALLATION?
We offer calibration and maintenance services for the equipment in your cleanroom. We offer secondary packaging and distribution services for the products you may manufacture in your cleanroom. Additionally, we can also provide GMP trained operators to supplement your team. Lastly, our team can provide training for your staff to ensure optimal use and regulatory compliance.
Benefits:
- Using a ready-to-use GMP flex space eliminates the need for companies to build or renovate their own facilities, which can be time-consuming and costly. Instead, they can quickly access an equipped and compliant space, allowing them to start operations promptly and avoid significant upfront investments. Allows the client to further protect their intellectual property without having to transfer it to another entity.
- Flexibility is a key aspect of GMP flex space. It enables companies to scale their operations as needed, whether it’s increasing manufacturing capacity, expanding research capabilities, or accommodating changing production requirements. This adaptability helps businesses optimize their resources and respond to market demands effectively.
- Opportunities for collaboration and networking among different pharmaceutical companies or research organizations occupying the various suites. Proximity to other industry players can foster knowledge sharing, partnerships, and innovation within the pharmaceutical sector.
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