503A/B Compounding Pharmacies

Our Team can consult, design, build, and certify your 503A/B facility.

Is your compounding facility registered or looking to become a registered 503A or 503B cleanroom cleanroom?

Where do you begin? What is required? Is the registration with the FDA necessary? How do you maintain the process? If these are questions you are facing, choose Cleanetics to walk you through the process and ensure that you are on the right path to FDA approval.

Cleanetics has been design/building 503A/B cleanroom facilities that meet the FDA requirements from design to certification.  Working closely with our clients’ we can develop a cleanroom that meets your sterile compounding regulations and can provide your facility the opportunity for expanded growth.  Our staff is highly trained in the 503A/B field and stays up to date on all USP Federal Regulations to keep you in compliance.

One of our past projects consisted of a turnkey design/build cleanroom construction for a 900 sq/ft hazardous compounding pharmaceutical production line facility.

  • Built in an open warehouse
  • Custom 30 ton Trane RTU with CRC controls
  • Segregated negative and positive ISO7 anteroom/buffer room
  • ISO 5 critical negative pressure compounding cleanroom
  • Bio-Gard Wall Laminate System
  • Homogenous, non-porous and durable
  • Capabilities to expand in the future without interruption to the existing compounding.

Frequently asked questions by our customers

  1. We are looking to expand our compounding production and outsourcing capabilities. What do we need to become 503B registered? -Independent Pharmacist
  2. Are we preparing sterile compounded drugs/hazardous/non-sterile?
  3. Do we wish to register as an outsourcing facility?
  4. We are not a registered pharmacy but do have a pharmacist that will supervise all compounding?
  5. Will our facility obtain or not obtain prescriptions for identified individual patients?

Cleanetics offers our clients preventative maintenance packages to extend the life of the cleanroom

  • Monthly, quarterly, or semi-annual packages
  • Certification to ISO Standard 14644-1
  • BSC/LAFW equipment certification
  • Aerosol filter scan
  • Inspect all equipment for proper operation
  • HVAC inspection and cleaning; Clean/replace FFU/HEPA pre-filters; Clean/replace FFU/HEPA pre-filters
  • Return air risers and wall cleaning
  • Pressure, Temperature, and Humidity Monitoring
  • Review cleaning procedures for compliance
  • Return air risers and wall cleaning
  • Microbial Viable Testing (Air and Surface)
need help? call us!
CONTACT US
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+1 (412) 405-8692

If you are in need of a cleanroom or have questions about our adaptable isolation units, please use our form or call us today. National and International inquiries welcome.

CLEANETICS

6850 N. Haggerty Road
Canton, Michigan
48187, U.S.A.

Phone:  +1 (412) 405-8692

© Copyright 2020 Cleanetics, LLC. All Rights Reserved
Oryan Agency
© Copyright 2020 Cleanetics, LLC. All Rights Reserved
Oryan Agency