We offer "first of its kind" cleanroom facility services for bio-entrepreneurs/incubatees/startups/ventures related to medical devices for manufacturing and packaging of medical devices.
Diverse team involved in activities like Quality Assurance, Quality Control, Engineering & Maintenance, Human Resources ensuring customer satisfaction, safety, and effectiveness of the quality Management System.
Provision of cleanroom facility services for the manufacturing and packaging of non-active medical devices, active (non-implantable) medical devices, implantable medical devices, in vitro diagnostic medical devices.
We are ISO 13485 certified.
Services
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Cleanroom Facility - Rent our qualified and functional cleanroom facility.
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Test License Support - Qualified and functional cleanroom facility documentation (Site Certificates, Layouts, Site Master File, etc) for submitting to the regulatory authorities.
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Manufacturing as a Service (coming soon) - Manufacturing, packaging, sterilization (dry heat, irradiation, gas) from third party with additional cost, quality control and packaging tests and supply to client or client’s customer.
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Packaging as a Service (coming soon) - Primary and Secondary Packaging of devices in cleanroom and sterilization (dry heat, irradiation, gas) from third party with additional cost, quality control and packaging tests and supply to client or client’s customer.
Terms & Conditions and Pricing
Virtual Tour - MedTech Cleanroom
Features
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Cleanroom facility comprises ISO Class 7 (Class 10,000), ISO Class 8 (Class 100,000), and ISO Class 9 areas.
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Areas linked with dynamic pass box for assembling and packing medical devices.
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Laminar Air Flow ISO Class 5 (Class 100) present in ISO Class 7 area.
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Equipment includes BOD Incubator, Hot Air Oven, Tensile Strength Tester, GP-10-DX, Pouch Burst Tester 415DA, Rotary Sealer HM 890 DC-V, Blister Sealing machine C400XP.
Photo Gallery
Equipment Suite
Laminar Airflow
Industry Applications
- To maintain a clean and sterile contamination controlled environment.
Benefits
- ISO Class-5 air purity.
Cartolux Sealing Machine
Industry Application
- Used for sealing flexible packaging to ensure product safety.
- Employed in the blister packaging of medical devices, providing tamper-evident seals.
Benefits
- Reliable and robust seals to protect product integrity.
- Versatile sealing for various materials
Hawo Rotary Sealer
Industry Applications
- Used for the automatic closing of sealable pouches and reels (Sterile Barrier Systems, SBS) in hospitals (CSSD) and the medical industry.
- Employed in the packaging of reels and pouches to maintain sterility.
Benefits
- Ensures sterile integrity of medical packaging.
- High throughput with consistent sealing quality.
Tensile Strength Tester
Industry Applications
- Used in quality control to measure the tensile strength of materials, ensuring product durability and compliance with specifications.
- Utilized in material research and development to test the mechanical properties of new materials
Benefits
- Accurate measurement of material properties.
- Ensures compliance with industry standards.
Pouch Burst Tester
Industry Applications
- Used in packaging industries to assess the burst strength of pouches, ensuring they can withstand internal pressure without failing.
- Employed in quality assurance for medical device packaging to verify the integrity of seals.
Benefits
- Ensures packaging durability.
- Prevents product contamination by verifying seal integrity.
Our Clients
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FAQs
What types of medical devices can be manufactured and packaged in
your cleanroom facility?
Our cleanroom facility supports the manufacturing and packaging of non-active medical devices, active (non-implantable) medical devices, implantable medical devices, and in vitro diagnostic medical devices.
What are the classifications of the cleanroom areas available?
Our cleanroom facility includes areas classified as ISO Class 7 (Class 10,000), ISO Class 8 (Class 100,000), and ISO Class 9. Additionally, we have Laminar Air Flow ISO Class 5 (Class 100) within the ISO Class 7 area.
What equipments are available in the cleanroom facility?
Our cleanroom facility is equipped with a BOD Incubator, Hot Air Oven, Tensile Strength Tester, GP-10-DX, Pouch Burst Tester 415DA, Rotary Sealer HM 890 DC-V, and Blister Sealing machine C400XP.
Can I rent the cleanroom facility for my own manufacturing needs?
Yes, you can rent our qualified and functional cleanroom facility for your manufacturing and packaging needs.
What is included in the Test License Support service?
Our Test License Support service includes the provision of necessary documentation such as Site Certificates, Layouts, and Site Master Files, etc which are essential for submitting to regulatory authorities.
How can I get a quote for using your cleanroom facility?
To get a quote, please contact us through our website’s contact form or call our customer service team. We will provide a customized quote based on your specific requirements.
Do you provide support for regulatory compliance?
Yes, we provide comprehensive support for regulatory compliance, including the necessary documentation and guidance for submitting to regulatory authorities. For further assistance please contact rifc@web.venturecenter.co.in, chetna@web.venturecenter.co.in
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