FDA cGMP compliance

Challenges

In industries where high levels of cleanliness and complete lack of bacterial growth are business-critical for packaging and sterilization of products, being FDA cGMP compliant is often a requirement. Complying with FDA cGMP requirements ensures that staff, patients and products are protected against issues related to contamination and bacterial growth. In other words, FDA cGMP compliance is important, but because of the strict requirements, they can be hard to achieve without the right cleanroom solution for your business.

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Application areas

The industries that are affected by the FDA cGMP requirements are those which need to produce products in an aseptic environment with reduced risk of contamination, for example, organizations, pharmaceuticals, compounding, and healthcare. These types of operations require a closely monitored environment where all exposed surfaces are non-porous and easy to clean, where bacterial growth, temperature, humidity, and the levels of particles in the air are controlled so that the risk of contamination is minimized. Without this continuous monitoring, the products and drugs being manufactured could be contaminated, putting staff, patients and the organization at risk.

Medtech
Compounding
Pharma
Production industry
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Solutions

QleanSpace FDA cGMP is a freestanding room-within-a-room cleanroom solution that ensures a controlled environment. We offer a customizable solution to meet your specific needs for FDA cGMP classification, room size, and other requirements. QleanSpace can be installed in most environments, and changed or relocated if necessary. It uses multiple individual HEPA 14 fan filter units and airlocks to generate positive pressure. The monitoring system controls data points of interest, for example particle levels, airflow, relative humidity, and air pressure. In addition, it uses non-organic materials with smooth surfaces and corners that meet the strictest requirements for particle release to ensure easy cleaning. Consultation, design, installation, and functional guarantee come with the cleanroom to give you a hassle-free solution. Function control, preventive service and regular maintenance all help you maintain your desired cleanroom classification.

Reduce the risk
of contamination

closely monitored icon

Closely monitored
environment

Increased
product quality

Hassle-free installation and use

Hassle-free,
delivered as a service

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