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SKM experience and expertise comprised of highly qualified engineers. The team dedicated to manage process performance and avoided down time. Here are SKM, we attach great importance to testing and periodical inspections in order to bring a greater economical value to our customer.
24/01/2026
Our key equipment including freeze dryers, liquid preparation systems, BFS, isolators and bioreactors has been upgraded to fully meet EU GMP standards, covering aseptic control, data integrity, CIP/SIP and validation. It supports pharmaceutical companies in passing GMP audits and serves the EU and global high-end pharmaceutical market.
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23/08/2025
Adopt Contamination Control Strategy (CCS) Hygienic design: 316L, dead-end free, full drainable Data integrity (ALCOA+) with audit trail Full lifecycle validation: DQ/IQ/OQ/PQ Equipment Compliance Freeze Dryer: SIP/CIP, hygienic chamber, precise data recording Liquid Preparation System: Closed piping, auto CIP/SIP, online monitoring BFS: Aseptic enclosed filling, particle monitoring, seal integrity Isolator: ISO Class 5, airtight, VHP sterilization, RTP transfer Bioreactor: Aseptic design, auto control, full process traceability
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