Pharmaceutical

Pharmaceutical manufacturing is governed by strict regulatory requirements (Schedule M, WHO-GMP, USFDA) that mandate precise environmental control. Relative humidity deviations during API synthesis, granulation, tablet coating, and lyophilization can compromise product potency, dissolution rates, and shelf life. Efflorescent compounds require RH below 20%. Hygroscopic APIs can degrade in minutes at elevated humidity. Cleanroom HVAC must deliver consistent temperature and humidity 24/7/365, with validated documentation. Any filtration failure in sterile manufacturing can result in product recalls and regulatory action.

Solutions Powered By

• Munters precision desiccant dehumidification for tablet manufacturing and coating lines
• Low dew point humidity control for lyophilization loading/unloading areas
• Granulation room climate control to prevent over- or under-wetting
• Packaging hall humidity control for blister and strip packing lines
• Mann+Hummel HEPA-grade cleanroom filtration systems
• Sterile-grade liquid filtration for WFI and process water systems
• Validated, documented systems for regulatory audit readiness