Comply to the ISO 13485 in Medical Device Manufacturing

Any organizations that design, produce, install or service medical devices should follow ISO 13485 standards to comply to regulatory requirements. The ISO 13485 Quality Management for medical devices is an internationally agreed standard that sets out the requirements for a quality management system (QMS)specific to the medical devices industry and aligns with the FDA 21 CFR Part 820.

Contact lens manufacturing is a perfect example of a quality focused industry that should maintain high standards in line with ISO 13485. The processes in contact lens development, manufacturing, testing and distribution present many challenges and several critical environmental parameters must be controlled and then monitored.

• Temperature
• Humidity
• Oxygen (O2) & Carbon Dioxide (CO2)
• Differential Pressure (DP)

Incorrect control of these parameters can affect the final products resulting in lost batches or worse creating patient risks such as microbial infections, allergies and damage to eyes. Monitoring and control are half the battle. In modern businesses simple access to data, trends and deviations is critical to allow busy staff to identify violations without being overwhelmed by data and false alarms. Quality management teams need clear reports suitable for clients and auditors.

Control

• For over 55 years Rotronic has developed and supplied precision humidity and temperature devices. Accuracy, ease of calibration, low drift and reliability are key features of these products. Multiple relative humidity and temperature transmitters also offer differential pressure measurement capabilities designed to meet clean room requirements.
• With an unmatched product mix we can offer O2/CO2 instrumentation for any application.

Monitoring

Rotronic Monitoring System (RMS) is a world class environmental monitoring system which has been developed specifically for regulated applications. RMS software and hardware is designed for stricter FDA 21 CFR Part 11 and EU Annex 11 regulations.

An ISO is only a guideline and not a regulation and as of such is not mandatory but does offer various benefits such as demonstrating compliance with regulatory and legal requirements and ensuring the establishment of QMS practices that consistently yield safe and effective medical devices. RMS helps fulfil the following ISO 13485 requirements:

• 6.3 Infrastructure
• 6.4 Work Environment and Contamination Control
• 7.5.1 Control of Production and Service Provision
• 7.5.6 Validation of Processes for Production and Service Provision

Project Examples

The initial requirement was temperature monitoring within clean room areas used for microbiology and analytic chambers. However, a wide range of assets also needed monitoring including incubators, climatic chambers, ultra freezers, media storage and sterility testing areas. Initially only relative humidity and temperature monitoring was required. Using a complete RMS solution gave the client the precision measurement they required as well as a compliant monitoring system that was easy to use, secure and met all regulatory requirements. The ability of RMS to monitor O2 and CO2 was of interest for future expansion.

Production areas require an inert environment for optimal quality. Specifically, <1% Oxygen. Monitoring is required for both quality control and human safety. Over 2’000 Ntron O2 analyzers are used on-site, reliable sensors and high level local of support were critical for the client.

Summary

Medical device industry covers a wide range of applications and companies. All activities must meet regulated standards. Contact lens manufacturing is a perfect example of medical device manufacturing that must adhere to these strict requirements.

The PST group offers a unique mix of products and services for this industry, from gas analysis and data loggers to complete monitoring systems with validation and calibration services. Our teams have built up years of technical experience to help our guide our clients with measurement, monitoring and regulatory challenges.