Isolators for ATMPs: The Challenge of Manufacturing ATMPs in Sterile Environments
Advanced Therapy Medicinal Products (ATMPs), such as cell therapy, gene therapy, and tissue engineering, present unique manufacturing challenges.
Unlike traditional pharmaceuticals, these biological products generally cannot undergo terminal sterilization. This makes continuous monitoring of critical environmental parameters (temperature, humidity, particle count, etc.) essential to ensuring process integrity.
One of the primary risks in ATMP manufacturing is microbiological contamination, which can compromise product quality and patient safety. GMP (Good Manufacturing Practice) regulations allow production in either open or closed systems:
Open Systems: Require a Grade A clean area with a Grade B surrounding environment, which entails high costs and complex infrastructure.
Closed Systems (Isolators): Allow Grade A production within a Grade D environment, optimizing safety while reducing investment in clean rooms.
In this context, Litek Pharma isolators provide the best solution for the safe and efficient manufacturing of ATMPs.
Litek Pharma Isolator Technology: Safety, Efficiency, and GMP Compliance
Litek Pharma isolators are designed to provide a sterile, airtight, and controlled environment, ensuring the integrity of ATMPs from production to release. Their key features include:
Validated and Sterile Production Environment
Litek Pharma isolators maintain a Grade A environment, protected by a HEPA-filtered unidirectional airflow system, ensuring a particle- and microorganism-free workspace.
Automated and Secure Decontamination
The hydrogen peroxide vapor (H₂O₂) decontamination system achieves a 6-log reduction before process initiation, guaranteeing a validatable and repeatable sterility level.
Aseptic Transfer Systems
To prevent cross-contamination, the isolators feature:
Modular equipment that can incorporate one or two airlocks or material transfer systems with VHP. These systems enable effective decontamination of products before introduction into the isolator, ensuring a controlled and safe environment.
Integration with Other Equipment
The modular design of Litek Pharma isolators allows integration with essential ATMP production equipment, including:
Centrifuges
CO₂ incubators
Microscopes
Fill & Finish solutions
Lyophilizers
Compliance with International Regulations
Litek Pharma isolators meet the highest regulatory standards:
GMP Annex 1 (Sterile Manufacturing)
ISO 14644-7 (Cleanrooms and Separative Devices)
ISO 10648-2 (Containment Enclosure Airtightness)
Benefits of Isolators in ATMP Production
Implementing isolators in the production of advanced therapies provides key advantages for the biopharmaceutical industry:
Enhanced safety by eliminating the risk of external contamination.
Reduced operational costs by minimizing cleanroom classification requirements.
Strict regulatory compliance to ensure process validation.
Operator protection when handling high-risk biological products.
Litek Pharma isolators are designed to adapt to the specific production processes of ATMPs, providing a scalable, efficient, and regulatory-compliant solution.
Contact us to learn more about our isolators and their applications in ATMP production.
