Transcript
Page 1: What Does Quality Mean?

All leafl ets are available on: www.asconumatics.co.uk

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Layout valve cluster

What Does Quality Mean?

The complete satisfaction of our customer is our ultimatebenchmark for quality.

The prerequisite for quality is not only a functional productbut also that the quality concept is applied comprehensivelyto all areas of our business.This includes research and development, production,suppliers, services and our sales team.

The Fundamental Areas ofour Quality Policy:

Products and Services:An accelerated implementation of customized solutions isachieved with personal conversations and direct customerinput.This is supported by our specialization throughdevelopment and production areas with efficientexperience and extensive training requirements.

Customized valve solution for a process application

Test stand sterilization process simulation. Cycle and lifetimetesting of diaphragms and valves with saturated steam.

Customers:Our customers are our employers and we are committed to making their visions come to life. We tailor solutionsaccording to our customers’requirements, working togetherwith them to provide cost effective results.

Page 2: What Does Quality Mean?

All leafl ets are available on: www.asconumatics.co.uk

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Qualification, Certification and Documentation

· Quality Management System according to DIN EN ISO 9001

· Pressure Equipment Directive No. 97/23/EC for the module D1

· Welding process AD-Certificate HPO/TRD201/TRR 100 and DIN EN 729-3

· 3-A Sanitary Standards Section 54-02

· Re-stamping authorization according to §2 (2a) German Equipment Safety Law (GSG)

· Welder qualification according to DIN EN 287

· Certificate of Compliance according to EHEDG Document No. 8 for diaphragm valves

· Certificate of Conformity of the diaphragms according to FDA CFR Title #21 Section 177

· Certification of Conformity of diaphragms according to USP Class VI - Test Section #87 & #88

· Certification of Conformity of the diaphragms according to 3-A

· Quality handbook and quality plan

Page 3: What Does Quality Mean?

All leafl ets are available on: www.asconumatics.co.uk

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Testing

Internal Surface Finish:· 100% visual inspection· Profilometer inspection as per specification

Weld Seam Testing:· 100% visual inspection· 100% boroscope inspection of all weld seams not directly visible with the eye or as per specification· 100% pressure testing

Diaphragm Valve Seal Test: · Test according to DIN EN 12266-1· 100% valve assemblies seal tested

Complete Valve Assembly Inspection:· 100% according to checklist

Non-Destructive Testing: (on demand or internal specification requirements)· Delta Ferrite · Porosity testing by liquid penetration · X-ray

Verification Certificates accordingto Specification DIN EN 10204:· 3.1 Analysis of the material traceability by heat number (U.S. Certified Mill Test Report-MTR). This also applies to all ASME BPE compliant material used in fabrications.· 2.2 Confirmation of conformance by documentation of results· 2.1 Confirmation of conformance with the specification

Boroscope inspection of the interior surface and weldseams of valves for aseptic applications

Delta Ferrite measurement of stainless steel valve bodies

Checklist

3.1 Analysis of the material


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