Quality
High-Quality Packaging with Cleanroom Manufacturing
Oliver's unwavering commitment to quality drives everything we do—from upholding the highest standards in cleanroom manufacturing to investing in products and technology for increased cleanliness. Oliver's converting facilities are ISO 13485 certified and adhere to the ISO 14971 risk management standard. With class 7 and 8 cleanrooms and a class 5 laminar flow hood, Oliver can meet cleanliness standards across the medical device, pharmaceutical, biopharmaceutical, and diagnostic industries.
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Quality Expertise
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ISO 13485 Certified
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Cleanroom Manufacturing
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ISO 14971 Risk Management Compliant
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Annual cGMP Training
Standards & Regulations
With decades of global manufacturing expertise, Oliver understands the complex regulatory environments you face. Let Oliver guide you through with confidence.
US-based manufacturers and distributors count on the expertise of our on site process validation services to guide you through the regulatory requirements established by the Food and Drug Administration (FDA) for Class I, II, and III medical devices.
Recently, the European Medical Device Regulation (EU MDR) increased medical device safety and effectiveness in the European market. We have the expertise to help our customers meet the packaging challenges presented by these protocols.
Our knowledgeable and experienced team can help ensure that our customers’ devices comply with regulations set forth by the China Food and Drug Administration (CFDA).
Oliver's commitment to patient safety and product quality is driven by top management and shared by all Oliver employees. We're proud that our quality program meets the stringent standards of medical device, biopharmaceutical, pharmaceutical, and diagnostics manufacturers worldwide. Review our standard quality survey.
Related Education
Packaging 101: ISO 11607
ISO 11607 outlines essential requirements for designing, testing, and validating packaging systems that maintain sterility and ensure patient safety in healthcare environments.
Unwritten Rules of ISO 11607
Parts of ISO 11607 are open to interpretation, requiring professionals to distinguish between mandatory requirements and areas where they must determine how best to apply the standard based on their specific packaging context.
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Why are Cleanrooms Important in Medical Packaging?
Cleanrooms are essential in medical packaging because they provide controlled environments that maintain sterility, reduce particulate contamination, and ensure high product quality throughout healthcare packaging processes. [oliverhcp.com]
What is Aseptic Manufacturing?
Aseptic manufacturing refers to the process of producing and packaging medical and pharmaceutical products in a sterile environment to prevent contamination by pathogenic microorganisms.