Mould testing & optimisation

We specialise in conducting comprehensive mould testing to establish a robust processing window for each mould. Our approach to Process Optimisation typically involves:

• Taguchi, G&A, or other statistical technique used to determine key process variables in the design of experiments
• Process parameter values are established
• Cpk determined

Confirmation – Run 1

• Optimised settings ran to confirm part quality is acceptable
• Critical dimensions measured using contact (CMM) or non-contact (optical) measuring equipment to compare results with initial trial

Process Capability

• Critical dimensions measured using contact (CMM) or non-contact (optical) measuring equipment to determine Cpk and final mould sizing

Confirmation – Run 2

• If mould re-sizing takes place following process capability, further measurements are carried out to confirm the changed dimensions and to ensure the required Cpk is achieved

Validation Protocol

Avenue’s significant expertise in validation (IQ, OQ, PQ), Class 8 (100,000) cleanroom, and in-depth knowledge of regulatory requirements has earned us a reputation for excellence among our customer base. Our capabilities include in-house protocol generation, with validations also carried out to customer supplied protocols. In both instances all validation protocols and reports are sufficiently comprehensive to meet FDA (code of Federal Regulations, 21CFR, part 820) and Global Harmonisation Task Force (GHTF) Process Validation Guidance.