USP Pharmaceutical Compounding – Sterile Preparations

BA Sciences provides services to help organizations ensure their cleanrooms comply with standards for sterile preparations in pharmaceutical compounding. We monitor changes to guidelines and protocols as you focus on your core capabilities, confident that experts are in your corner.

New Revisions to USP <797> Pharmaceutical Compounding – Sterile Preparations

minimum standards to be followed during the preparation of compounded sterile preparations (CSPs) for both human and animal drugs. As part of these new guidelines, there are increased requirements for environmental and personnel monitoring during sterile compounding processes.

BA Sciences has the expertise to support the environmental monitoring of both cleanroom facilities and compounding personnel. BA Sciences provides on-site services for cleanrooms and USP <797> compliant laboratories.

What Is Sterile Compounding?

For USP <797> purposes, you can define sterile compounding as the process to pool, admix, dilute, combine, repackage, or reconstitute substances used in bulk drug or drug production, with the goal of developing sterile medicine.

What Types of Individuals and Facilities Must Comply With USP <797>?

USP <797> standards apply to any organization or individual preparing CSPs for use with animal or human patients, including:

  • Hospitals
  • Surgical facilities
  • Pharmacies
  • Infusion centers
  • Physicians
  • Nurses
  • Technicians
  • Pharmacists
  • Chiropractors
  • Naturopaths
  • Dentists
  • Veterinarians

If your duties require you to prepare a CSP for any reason, you are obligated to adhere to USP <797> guidelines.

Steps for Staying in Compliance With USP <797> Cleanroom Guidelines

Operating a cleanroom requires individuals and facilities to comply with USP <797> cleanroom guidelines, with a focus on personal hygiene and attire, and procedures for disinfecting and cleaning compounding areas:

Garbing and personal hygiene protocols

Because the majority of microbes found inside cleanrooms come from people, it’s essential that individuals are properly trained in garbing and maintaining the requisite level of personal hygiene.

BA Sciences will help your organization stay on top of current guidelines, such as the new mandate that people can no longer reuse disposable gowning material (garbing) in the updated USP <797> cleanroom guidelines. After laundering, you now need to re-sterilize garbing items.

Disinfecting and cleaning compounding areas

Under USP <797>, your organization must consistently disinfect and clean your compounding facilities. When using a one-step disinfectant registered with the Environmental Protection Agency (EPA), you can do cleaning and disinfecting simultaneously. Be aware that you must also employ sporicidal disinfectants every month.

To ensure your team adheres to these guidelines, develop and deploy quality control and quality assurance procedures, noting the responsibilities and methods you’ll use to prepare compounded medications to meet standards for patients.

BA Sciences can help you develop your training and documentation, standard operating procedures, protocols for testing and verification, hygiene, and cleaning.

Partnering With BA Sciences

BA Sciences provides state-of-the-art, on-site microbial air and surface environmental monitoring services for cleanrooms and USP <797> compliant laboratories. Our team brings years of experience and follows best practices to ensure our customers’ facilities meet current standards.

Ready to get started? Tell us about your upcoming project

Get an Accurate, Timely Quote
Tell Us About Your Project