GMP 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 GMP compliant is often a requirement. Complying with GMP requirements ensures that staff, patients and products are protected against issues related to contamination and bacterial growth. In other words, GMP compliance is crucial, but because of the strict requirements, they can be hard to achieve without the right cleanroom solution for your business.
Application areas
The industries that are affected by the GMP requirements are those which need to sterilize and package products without any risk of contamination or bacterial growth, for example, organizations within medical technology, pharmaceuticals, compounding, and healthcare. These types of operations require a closely controlled environment where all exposed surfaces are non-porous and easy to clean, where temperature, humidity, relative pressure, and level of particles in the air are monitored so that the risk of contamination is minimized. Wihout this continuous monitoring, the products and drugs being manufactured could be contaminated, putting staff, patients and the organization at risk.
Solutions
QleanSpace GMP 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 GMP 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 Lifetime Performance 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.
Safe and healthy
indoor air
HEPA 14-filtration against
viruses and bacteria
Ensured product
quality
Hassle-free,
delivered as a service
