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Single Use Systems for PUPSIT
MDI provides a customized single use systems for aseptic filtration single use PUPSIT designed to overcome challenges by addressing all PUPSIT requirements, ensuring process reliability, regulatory compliance, and providing maximum efficiency.
Process Support
It provides stability and support for PUPSIT assemblies during
- Pre-use integrity testing
- Aseptic filtration
- Post-use integrity testing
Cleanroom operations
Easy to clean and disinfect SS 316L construction, suitable for ISO Class 5 (Class A) cleanrooms
Risk Mitigation
- Minimizes risk of disconnection or damage to PUPSIT single use systems
- Equipped with lockable wheels for stability and grip
Custom Design
Customized design and accessories such as filter holders, bag trays and tubing clamp holders for custom PUPSIT Single Use Systems
| Clean Room Manufacturing | PUPSIT assemblies are manufactured in clean rooms certified by external agencies and monitored in-house for viable and non viable particles. Employee hygiene, change rooms, gowning and de-gowning procedures and continuous monitoring of the areas is an essential part of these facilities. These facilities have been designed for unidirectional work flow with appropriate change rooms for personnel and air locks for material movement. |
| Quality Management Systems | PUPSIT assemblies are well designed products with in-built quality assurance. ISO-9001:2015 Certified Quality Management System, careful selection of raw materials, validated production processes and testing procedures based on international standards and guidelines such as CFR, PDA, and ASTM, ensures manufacture of consistently high quality assemblies. |
| Regulatory Compliance | PUPSIT assemblies are deeply characterized and validated to meet international regulatory requirements with regards to bioburden, endotoxins, particulate matter and extractables. |
| Customization | MDI PUPSIT single use assemblies can be customized to suit user requirements in terms of filters, high pressure tubing, connectors, tube fittings, bags, transfer tubes, tube clamps, and vent filters. |
| File Type | Download |
|---|---|
| Datasheet | Download |
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