Learn More: ISO, cGMP and FDA Certifications
Tips for Passing ISO, cGMP, FDA and Other Certifications
Know your ISO requirement
A Terra product specialist can offer general design advice or make a consultation referral. Regulated industries such as pharmaceutical compounding maintain clear requirements for ISO cleanliness and related cleanroom characteristics. Other operations may require a certification consultant to specify these design requirements based on specific operations being performed.
Either way, make sure you know the applicable performance requirements before you select a room design or cleanliness level.
FFU Ceiling Coverage and Air Change Rate
ISO specifies permissible particle counts for each cleanliness level but not how many fan/filter units are required to meet these target values. Other organizations, including the Institute for Environmental Science, provide recommended ranges for FFU ceiling coverage.
Terra recommends the high value within each range, which in most cases accommodates typical contamination loads presented by personnel and equipment. Modular Power Distribution Modules make it easy to add as requirements change – plug-and-play connections eliminate the need for hard-wiring by an electrician.
Cleanroom Design and Materials
A Terra Product Specialist will advise on the proper panel and other component materials to meet specific requirements for ISO compatibility, sterilization, chemical resistance, static safety, and other environmental concerns.
Environmental Control and Documentation
Adjustable exhaust vents and manual FFU speed controls on all Terra cleanrooms allow regulation of air change rates. For centralized display and control, select low-cost automated FFU speed controls, which also allow remote Building Management System (BMS) fan control and even dynamic fan adjustment in response to programmed pressure levels. Air pressure, temperature, and humidity data are logged for a traceable operating history.
Modular cleanrooms are available with stand-alone air conditioning modules or can be integrated with existing A/C systems. Humidification and De-humidification systems meet specific RH requirements.