Biochemical & R&D Labs, Hospitals, Cleanrooms & Pharmacies

 

R&D Labs, Pharmacy, Hospitals, & Specific Industries

  • Medical Devices (class 1, 2 & 3 according to FDA 21 CFR 860)
  • Laboratories and cleanrooms surgeries within Hospitals (USP 797)
  • Intensive care unit, Tissue culture labs, Operating suites, Sterile processing, Oncology unit
  • Pediatric unit, Bone marrow transplant unit, Burn Unit, Blood banks
  • Laboratories and cleanrooms sterile injectable preparation for Pharmacies (USP 797)
  • Laboratories for Chemical and microbiological analysis
  • R & D laboratories
  • Micro-electronic & Nanotechnolgy laboratories and cleanrooms
  • Nutraceuticals & Cosmetics
  • Natural Healthcare products
  • Fine Chemicals
  • Food & Drink
  • Biofuels, BioEthanol, BioDiesel, Pyrolytic Oils
  • Building Services & Project management

PBE provides additional professional services related to the design of process, equipment & cleanrooms, dedicated to the preparation of sterile injectables according to USP797 & ASTASS regutations & stadards.  At least the following injectables are prepared: parenteral nutrition, antibiotics, vaccines, ophthalmics, narcotics, chemotherapy, cytotoxics & diabetics, topic solutions, and biotech.

In USA, OSHA and NIOSH have set regulations for the safe manipulation of high potent and toxic compounds in the pharmacy such as hormones and cytotoxics drugs to cover the following activities at risk :

  • Safe compounding of powder
  • Sterile compounding & mixing preparation
  • Laminar flow & biological hods, closed active or passive isolators
  • Chemo compounding
  • Modular cleanrooms & HVACs
  • Fan filter units (FFU)

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner