Production & Quality series · Part 2 of 2 · Read Part 1
Making a glove is straightforward. Making ten million gloves that all perform the same is the hard part. This is where the systems and processes at PharmShield make us a more reliable partner to the pharma industry. Part 1 covered how a nitrile glove is made. This part covers what sits on top of that process: the testing, tolerances, and traceability that give every glove the same performance and characteristics.
What “consistent” actually means
For a pharma buyer with critical processes and environments, consistency is mandatory:
- Every glove in a batch has to meet the same dimensions, thickness, and properties.
- Pinholes are limited and stay well within the defined acceptable limits across the batch.
- Every batch performs exactly the same as the last: the same fit, the same strength, the same properties.
That repeatability is what lets a pharma QA team qualify a glove once and trust it on every reorder.
The controls that deliver it
AQL 0.65 testing. AQL (Acceptable Quality Limit) defines the maximum allowable number of defects in a glove batch based on a statistical sampling plan. While ASTM standards specify AQL 2.5 and AQL 1.5 is the accepted norm for examination gloves, PharmShield applies a stricter AQL 0.65 acceptance level for pinhole defects, due to the more critical applications our gloves are intended for and for enhanced barrier protection.
How do we test for AQL 0.65?
Gloves are selected from a batch as per the ISO 2859-1 sampling plan, filled with water, and inspected for leakage. The batch is accepted or rejected against the defined sampling levels and acceptance criteria.
What does AQL 0.65 actually allow? From a sample of 200 gloves drawn from a batch under ISO 2859-1 single sampling (normal inspection):
| AQL level | Where it applies | Max defective gloves allowed (200-glove sample) |
|---|---|---|
| AQL 2.5 | ASTM minimum for examination gloves | 10 |
| AQL 1.5 | EN 455 norm for examination gloves | 7 |
| AQL 0.65 | PharmShield acceptance level | 3 |
Physical testing. Sample gloves are tested for tensile strength, elongation, and other key parameters before and after accelerated ageing, to verify durability and performance. Key dimensions (length, width, and thickness) are measured against defined specifications to ensure consistency. These controls maintain reliable fit, strength, and barrier performance from one batch to the next.
13 QA checkpoints.Quality isn’t a single inspection at the end; it’s 13 QA checkpoints built into the line, from incoming raw-material inspection, through the dipping process, post-production, and final release. Each checkpoint verifies the glove is meeting specs before it moves on to the next stage.
Batch traceability. Every batch is documented and traceable, so a customer can tie a delivered box back to its production record. This is a standard feature of every glove produced at PharmShield, and we are open to customer audits at any time to verify it.
No sourcing, no mixing. A manufacturer that buys in gloves from multiple vendors will find it difficult to maintain consistency in quality and fit. PharmShield produces every glove on its own line, with the same formulation, the same process, and the same tolerances.
Why it matters to you
A cheaper glove that varies batch to batch costs more than it saves: failed QC checks, line stoppages, re-qualification, and the risk of a barrier failure in a critical process. Consistency is one of the key criteria the PharmShield brand strives to provide, and the systems above are what deliver it. It’s why PharmShield operates as a specialty manufacturer rather than a commodity reseller, and why our pharmaceutical customers qualify us once and reorder with confidence.
See how the gloves are made for Part 1, browse our nitrile range, or request a spec sheet and samples.