Jul 22, 2019 · EU GMP and FDA requirements for cleanrooms were approved more than 30 years ago and Table 1 provides a sample of how they might differ:Table 1. Differences Between FDA and EU Cleanroom Requirements. FDA. EU. Particle sizes. 0.5 µm only. both
Pharmaceutical and Sanitary Heat Exchangers. P-Line a series of exchangers for pharmaceutical and food industries and suitable for all other applications that are in compliance with FDA and 3A. The unique construction of P-Line series exchangers reduces the risk of cross-contamination of the media even in the case of unsealing of the [AERRE INOX DTS HEAT EXCHANGER] - CPI TechnologyAERRE INOX DTS Heat Exchanger. Since 1990 Aerre Inox has been designing and making, in line with USP 23 and FDA norms, a full range of stainless steel tube shaft sterile heat exchangers with double tube sheet (DTS) for use in the chemical and pharmaceutical industries. Developed in compliance with FDA & cGMP rules, the special design (DTS
All heat exchangers, used for heating, cooling or both, are made with high quality standards in full compliance with FDA, cGMP and customer project requirements. The welding option, for sealing the tubes to the tube sheets, allows to fully comply with the ASME BPE regulations, already contemplated as the manufacturing standard for these devices.
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