For customers in the Pharmaceutical & Biotechnology sector, the effectiveness & consistency of cleaning is essential to prevent microbiological contamination of their systems & products. Nanjing Qirui can offer an efficient, repeatable, sensibly priced and validatable modular solution.
Features:
1. Versatile modular design: our "Skid" CIP Unit is compact, easy to transport and install.
2. Fully automated according to cGAMP principles in order to provide a repeatable and reliable cleaning process. Continuous
measurement & control of flow, pressure & temperature. The efficiency is verified by means of return conductivity or TOC measurement.
3. All data stored according to CFR 21 Part 11 requirements.
4. Double tube & s hell heat exchanger for hot option ensuring safe separation of cleaning media and utility.
5. Flexible design to optimize most workshop layouts.
6. High quality components. All materials in contact with the cleaning media are FDA approved, with certified/ documented traceability.
7. Cross contamination prevented by means of engineered barrier system.
8. Energy efficient, economical and environmentally friendly
9. 100% drainable with open design for easy maintenance.
10. Full documentation Package: P&ID, 3D drawing, dimensional and electrical drawings, maintenance and spare parts manuals, welding & inspection certificated, material certificates, DS, FDS, SDS, HDS, DQ, IQ and OQ.
Nanjing Qirui delivering innovative solutions for the pharmaceutical and biotechnology sectors , specializing in the turnkey provision of technically advanced and engineered solutions for the provision of process systems required in the production of a range of medicines including:
1. Vaccine
2. Antibiotic
3. Injectible & Infusion
4. Oral preparation, solid dosage and suspension
5. General use drug, cream and lotion
CIP/SIP system is designed and constructed to clean and sterilize production equipment in full compliance with cGMP guidelines in accordance with FDA and EP requirements.
Engineering and manufacturing practices follow ISO 9001 procedures and comply with internationally recognized standards and guidelines, such as ASME BPE and GAMP. Design and construction meets the most stringent regulations and codes from Europe and the USA.
To ensure the equipment meets requirements, Nanjing Qirui works in partnership with clients and a dedicated team follows an order as a unique project. Nanjing Qirui develops specific Quality Plans (DQ, IQ and OQ) and undertakes Factory Acceptance Testing (FAT) to give assurance, performance and quality.
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