ISO-Certified Cleanrooms for Medical & Pharma Manufacturing
Yenepoya Technology Incubator provides access to two dedicated cleanroom facilities, meticulously designed and maintained to meet stringent regulatory standards for pilot-scale manufacturing. These controlled environments are essential for producing medical devices and pharmaceutical formulations requiring high levels of cleanliness and contamination control.
Class 1000 (ISO 6) Cleanroom
Our ISO 6 cleanroom maintains particle counts of no more than 1,000 particles (≥0.5 µm) per cubic foot of air, creating an ideal environment for sensitive medical device manufacturing and pharmaceutical processes requiring high levels of contamination control.
Class 10000 (ISO 7) Cleanroom
Our ISO 7 cleanroom operates with particle counts below 10,000 particles (≥0.5 µm) per cubic foot, providing a controlled environment suitable for a broader range of medical device assembly processes and pharmaceutical applications.
Our Cleanroom Capabilities:
Medical Device Manufacturing
Equipped for the assembly and production of pilot batches and clinical trial (CT) batches of medical devices under controlled conditions.
Pharmaceutical Formulation
Capabilities for manufacturing bioreactor-based Active Pharmaceutical Ingredients (APIs) and various dosage forms, including capsules, tablets, gels, and creams.
Regulatory Support
We collaborate closely with startups to navigate the regulatory landscape, assisting in obtaining the necessary approvals for manufacturing test and CT batches.
Quality Assurance
Our facilities follow strict quality control protocols, ensuring that all products manufactured meet the highest standards of quality and safety.
Leverage our certified cleanroom infrastructure and expert support to advance your medical or pharmaceutical product from development to clinical trials and beyond, ensuring quality, compliance, and safety.