Continuous Improvement & Strict Compliance
The optimal sterile barrier systems come from ongoing continuous‑improvement programs. We keep optimizing across all operations by adhering to stringent ISO standards and regulatory requirements, deploying visual inspection techniques, and upgrading production equipment. Our facility is certified to ISO 13485, with an independently ISO 14644‑1 certified cleanroom, and completes full IQ, OQ, PQ validation for ISO 11607‑1 and ISO 11607‑2.
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