Quality Systems
Quality built into every solution
Quality is more than a certification. It is reflected in the way products are designed, manufactured, documented, inspected, and supported.
At ZOOK, our quality systems and manufacturing processes are focused on delivering reliable pressure relief solutions that support the performance, traceability, and documentation expectations of regulated pharmaceutical environments.
- AS9100 D / ISO 9001:2015 Certified Manufacturing – supporting consistent quality management, documented processes, and continual improvement
- Material Traceability – helping support documentation requirements from raw material through finished product
- Controlled Manufacturing Processes – supporting repeatable production, inspection, and testing activities
- Product Documentation & Records – helping customers support qualification, specification, and compliance-related documentation needs
Product Certifications & Registrations
Quality Built Into Every Solution
ZOOK rupture disk solutions are available with certifications, registrations, and compliance features that support use in pharmaceutical, biotechnology, and life science applications worldwide. These may include:
ASME UD Certification
For rupture disk devices manufactured and certified in accordance with applicable ASME BPVC Section XIII requirements
Pressure Equipment Directive (PED / CE)
For regulatory compliance, conformity assessment, and CE marking of pressure equipment for the European market
3-A Sanitary Certification
Supporting hygienic design requirements for sanitary processing environments
KOSHA Certification
Supporting applicable pressure equipment requirements for the South Korean market
EN 10204 – 3.2 Certificate per AD2000-Merkblatt A1 – available where applicable to support independent verification requirements
Our experience with these global requirements helps pharmaceutical manufacturers specify pressure relief solutions that support safety, documentation, and acceptance across facilities, markets, and applications.
Product certification matrix
| Certification availability across product families | ||||
|---|---|---|---|---|
| ASME UD | PED/CE | 3-A | ASME BPE | |
| ZANITARY® | Yes | Yes | Yes | |
| RAUS® | Yes | Yes | Yes | No |
| RLPS® | Yes | Yes | Yes | No |
| SD® | Yes | Yes | No | No |
| ARD | No | No | No | Yes |
Availability may vary based on configuration, materials, installation requirements, and application conditions.
Quality resources
Documentation available upon request.
To support qualification, specification, and project requirements, ZOOK can provide documentation for applicable products and certifications.
Available Resources:
- ISO Certification
- ASME UD Certificates
- PED / CE Certificates
- 3-A Authorization
- FDA / USP Class VI Material Declarations
- Product Datasheets
- Technical Literature
- Installation Guidance
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