Clinical Trials - Drug Development Cleanrooms

 

Clinical Pharmacology Research Suite

  • Application: Clinical Trials for Drug Development
  • Industry: Clinical Research – Phase 1 Unit
  • Cleanroom Class: ISO 7
  • Square footage: 400 square feet
  • Location: Nebraska, USA

 

This Contract/Clinical Research Organization (CRO) needed laboratories to provide clinical trials for their clients in the drug development market. The Phase 1 Unit now includes a suite with 4 individual cleanrooms for both hazardous and non-hazardous processes. A shared anteroom and a hazardous storage space complete the lab layout. Very limited space above the cleanrooms (only 18 inches) was challenging for ductwork installation, but Mecart’s engineers were successful and the complete HVAC system is in place.

"Mecart cleanrooms absolutely have that “Wow Factor” and our clients are beyond impressed." - Clinical Research Pharmacist in Charge

 

What is a Phase 1 Unit?

Clinical Pharmacology Research is the field of study focused on drug actions and interactions with living systems. A Phase 1 Unit of a clinical trial is the first time a medication is tested on humans. The purpose of testing during the drug development phase is to determine if the treatment is safe, if there are any side effects, and if it’s better than a medication or treatment currently on the market. In Phase 1, a small group of volunteers is selected based on their individual health history. Different dosages are given throughout the study and each volunteer is monitored to determine the drug’s effect. Once a drug passes Phase 1, it moves onto another level of clinical trials.

550 x 354 - cleanroom - clinical research - A & A photos
550 x 354 - cleanroom - clinical research - A & A photos (1)
550 x 354 - USP 797 and 800 cleanrooms - 3230
550 x 354 - USP 797 and 800 cleanrooms - 3230