Our Quality
Quality at Pacwell is built on controlled processes, measurable performance, and disciplined documentation. Our sterilization pouches and reels are manufactured using defined sealing parameters, traceable material sourcing, and batch-wise verification to ensure consistent performance in medical sterilization and handling environments.
How We Ensure Quality
A validated and repeatable process governs every step of production. Each input, parameter, and output is controlled and documented to ensure seal integrity, sterility maintenance, and consistent barrier performance.
Quality isn’t checked at the end – it’s built into the process. Our aim is simple: reliable, audit-ready sterile packaging every time.
Our Quality Process
1. Incoming Material Verification
We source materials only from trusted, audited suppliers. Each batch undergoes rigorous quality checks to ensure consistency, performance, and compatibility before it enters production.
2. Controlled Manufacturing Parameters
Sealing temperatures, pressures, dwell times, and machine speeds are defined and documented. Operators follow standard work instructions, with checks at critical control points to maintain repeatability.
3. In-House Performance Testing
Every production batch undergoes peel strength testing, burst strength checks, seal integrity evaluation, and visual inspection using NABL-certified laboratory equipment to ensure consistent performance.
4. Clean and Controlled Production Environment
Our manufacturing floor features epoxy-coated flooring, controlled airflow, and organised material movement designed to minimise particulate exposure. A cleanroom expansion is planned as part of our ongoing quality roadmap.
5. Batch Traceability & Documentation
Each batch is assigned a unique lot number, linked to material records, machine parameters, QC test results, and operator logs. This ensures accountability and seamless traceability for audit and recall control.
Certifications and Standards
Pacwell is currently in the process of obtaining ISO 13485 certification for medical device packaging. Our quality system is structured around documented procedures, batch traceability, equipment calibration control, and defined sealing parameters to support consistent and auditable production. As we expand, we are aligning our manufacturing and QA practices with global sterile barrier system requirements under ISO 11607 and relevant regulatory frameworks.
