GMP laboratories in hospitals

Pharmacy in a hospital with clean room airlocks — Example GMP laboratory

material pass box in a pharmacy in a hospital — Example GMP laboratory

modular wall system für gmp laboratories — Example GMP laboratory

GMP labarotory in modular construction — Example GMP laboratory

GMP wall construction with flush integrated window — Example GMP laboratory

GMP Lab, pharmacy, hospital — Example GMP laboratory

In a hospital, GMP laboratories are often located in close proximity to the clinical wards. They focus primarily on in-hospital pharmacies for the production of individual patient pharmaceutical products, the production of radioactive active and diagnostic substances or IVF. GMP (Good Manufacturing Practice) covers guidelines such as the EU GMP for quality assurance of production procedures and environments in the manufacture of medicinal and active pharmaceutical therapeutic products. Quality assurance plays a key role in this area, as any deviations in quality can have direct effects on the product and on patients' health.

As such, certain room requirements compliant with GMP need to be met, i.e. laboratory rooms must meet classes D to A according to EU GMP or other cleanliness requirements according to ISO 14644. Examples include the implementation of suitable pressure levels and modular room systems with correspondingly hygienic and smooth surfaces. With its expertise in this research area, HT can support you in this process from planning to implementation.

Areas of application for GMP laboratories

Clinic pharmacy

In addition to the supply of medicines and medical products, the hospital pharmacy focuses on the production of patient-specific medicines (e.g. cytostatics).

Ex Vivo Laboratories

This involves procedures or processes in which living biological material, such as cells, tissue or organs, is removed from a living organism and cultivated outside it for a limited period of time.

Pharma industry

Research and industrial production of pharmaceuticals under strict hygiene conditions in a controlled environment..

Biotechnology

Field of research that deals with the technical utilization of biological processes at the level of enzymes, cells, organisms, etc.

GMP Laboratory, Qualification, functional test

Safety from planning to operation

HT Group offers reliable planning of GMP laboratories for all areas of application and BIM-supported project execution on request.

All technical building systems and parameters are taken into account (TGA / MSR / monitoring), and special requirements can also be easily integrated thanks to the modular, variable system.
The specially developedGMP material airlocks in variable sizes are used for the safe entry and exit of materials, samples or pharmaceuticals. The sluice systems are available as active, partially active or passive material pass-throughs, multi-chamber airlocks or trolley sluice for transferring large and heavy materials and can optionally be equipped with EI60 fire protection.

A requirement with explosion protection in accordance with the ATEX directive for the chemical industry, pharmaceuticals or gas plants, for example, can also be implemented.

Qualification tests complete the construction project:

How are the cleanliness classes verified?

To define the cleanliness class, the particle concentration of the room air and the air exchange rate are measured during qualification
ISO 14644-3 and VDI 2083-3 define various measurement methods and limit values (= maximum permissible particle concentration per m³)

Pressure level measurement according to ISO 14644-3 and VDI 2083-3