Monitoring pre-engineered cleanroom solutions: ISO and GMP standards

Monitoring refers to the automated recording of parameters and the issuance of alarms and error messages. Significant differences exist in the implementation of monitoring systems, depending on the cleanroom classifications and standards. At ABN Cleanroom Technology, we offer two types of monitoring package for our pre-engineered cleanroom solutions: CleanConnect for environments according to ISO14644 and GMPConnect for environments according to GMP standards.

ADAPTUS – The first Product Platform Architecture in cleanroom design

The cleanroom industry, encompassing sectors such as pharmaceuticals, biotechnology and semiconductor manufacturing, stands to gain significantly from adopting a product platform approach. This strategy emphasizes developing a competitive set of modular products and services that are easy to integrate, meet future regulatory, market and societal needs, and exceed customer expectations. ABN Cleanroom Technology is the first company to introduce a product platform strategy in cleanroom design.

DryCell – The first ready to use low dewpoint cleanroom solution in EU

With the increasing demand for electronic devices and electric vehicles throughout the world, more and more manufacturers are running into the same problem: the supply of components, especially batteries, is not keeping up with the massive demand. To meet overall demand in time, additional facilities for production of lithium-ion batteries should be built in the short-term. Battery cell production is a mission critical challenge because the materials used in lithium-ion batteries react heavily with humidity. For that reason, we introduced DryCell.

Digitizing GMP validation processes

A company?s records are a prized possession and should be taken care of the best way possible. When we think of?good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of these records in good standing.?Records are official evidence proving that certain tasks have been completed as they should be ?evidence of compliance? and poorly documenting can negatively impact cleanroom process quality. In this article, we?ll shortly discuss paper records vs. electronic records for GMP processes.

GeneFab – Your ready-to-configure ATMP-facility

The demand for approved therapy medicinal products is increasing day by day. With GeneFab, ABN Cleanroom Technology introduces a ready-to-use Cell & Gene Therapy facility for large-scale ATMP production.

1. Off-site production, on-site assembling

Legolisation means standardisation. Standardisation causes a shift in production. Work is carried out in conditioned spaces such as factory halls. our cleanrooms are manufactured partly or entirely off-site, which means huge savings on transport costs and reduction of inconvenience on-site