| Customization: | Available |
|---|---|
| Application: | Cleanroom/Hospital/Food Factory |
| Model: | Clean Booth |
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A Pharmaceutical Turn-Key Clean Room Project involves a comprehensive solution for designing, constructing, equipping, and commissioning a fully functional, compliant clean room facility tailored specifically for pharmaceutical manufacturing purposes. This type of project typically includes:
Design & Consultation: A detailed assessment of client requirements followed by conceptual design and layout planning. It encompasses everything from architectural drawings to HVAC (Heating, Ventilation, and Air Conditioning) system design, electrical and plumbing plans, and ensuring compliance with international standards like FDA cGMP, EU GMP, and ISO guidelines.
Construction: Execution of the design plan, which can include building partitions, installing specialized flooring, walls, ceilings, and lighting systems that meet clean room specifications. The construction phase also covers the installation of airlocks, gowning rooms, and other ancillary areas.
Cleanroom Equipment Supply: Providing and integrating essential cleanroom equipment such as air handling units, HEPA filters, laminar airflow cabinets, pass-through boxes, decontamination systems, and process equipment specific to the pharmaceutical production process.
Validation: Conducting extensive testing and validation services to ensure that the clean room meets the specified ISO classification (e.g., ISO 5 or ISO 6) and all regulatory requirements. This includes particle counting, airflow patterns, temperature, humidity, differential pressure, and other environmental monitoring parameters.
Training & Commissioning: Once built, the provider offers training to the staff on how to operate and maintain the clean room facility properly. They also handle the commissioning process to make sure all systems function optimally before handing over the facility.
Ongoing Support: Post-commissioning support may include maintenance contracts, periodic re-validation, and assistance with regulatory inspections.
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