Pharma-Compounding_BioPharma

A traditional part of pharmacy practice, compounding involves the preparation of medications to meet unique patient healthcare needs that cannot be met with commercially manufactured drug products.

Of the approximately 56,000 community-based pharmacies, more than half provide some level of basic compounding services to local patients and physicians. The International Academy of Compounding Pharmacist (IACP) estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services of which approximately 3,000 provide sterile compounding.

All compounding pharmacies are governed by:

  • Food & Drug Administration (FDA) for the integrity of the drugs and Active Pharmaceutical Ingredients (APIs) which they order, store and use
  • Drug Enforcement Administration (DEA) for their handling of controlled substances used in the preparation of compounded medications

Additionally, sterile compounding practices are recommended by:

  • ISO 14644 series of international standards for clean rooms and associated controlled environments, and
  • USP-NF General Chapter 797 for Pharmaceutical Compounding—Sterile Preparations

All of these guidelines serve to provide ideal practices that will limit the possibility of introducing pollution into the compounding process that could result in harming a patient.

TOMI™ Environmental Solutions’ clean room protocol for bio-contamination control provides additional guidance into monitoring risk zones as well as how to assess and control bio-contamination. Implementing TOMI’s clean room guidelines with the use of SteraMist™ powered by Binary Ionization Technology® (BIT™) for disinfection/decontamination will kill pathogenic bacteria*, helping to maintain a controlled environment. Request the TOMI™ Environmental Solutions Clean Room Protocol.

SteraMist™ BIT™ Kills Bacteria* on Hard Non-Porous Surfaces

Compounding biologics, drugs, nutrients and radio-pharmaceuticals that need to be sterile when administered to patients mandates extensive precautions. Surfaces and equipment must be disinfected/decontaminated at the beginning of each shift, between each batch of products, and every 30 minutes as compounding continues throughout the day. A fast acting disinfectant complete in seven minutes after application, the SteraMist™ Surface Unit kills bacteria* and inactivates viruses** which can reduce the risk of potential exposure in a treated space.

Ideal for disinfecting/decontaminating treated hard, nonporous, high touch surfaces and equipment, the SteraMist™ Surface Unit can be used to disinfect:

  • Laminar Airflow Workbenches (LAFWs),
  • Biological Safety Cabinets (BSCs),
  • Compounding Aseptic Isolators (CAIs) and,
  • Compounding Aseptic Containment Isolators (CACIs)
  • Materials transferring into and out of aseptic compounding areas
  • Laboratory furniture
  • Surfaces after spills or mishaps

At minimum, it’s recommended that floors be cleaned and disinfected daily, and walls, ceilings, and storage areas be cleaned and disinfected monthly. Manual cleaning is appropriate to remove dirt from these surfaces but also leaves room for error. One missed spot can allow bacteria to colonize on surfaces and spread. SteraMist™ BIT™ goes above, beyond, under and around disinfecting sprays and wipes, reaching surfaces other disinfectants/decontaminants can’t. The SteraMist™ Environment System is ideal for clean rooms and HEPA filtration systems, preventing the colonization of bacteria on treated surfaces.

An effective broad-spectrum surface disinfectant, SteraMist™ BIT™ is great for use in all Pharmaceutical Spaces and is:

  • Easily incorporated into current cleaning procedures
  • Easy to transport and can be configured to treat multiple spaces simultaneously
  • Economical, non-corrosive, and easy to apply
  • Silver ion free, leaves no residues
  • Fully validated to comply with Good Manufacturing Practice (GMP) Standards
  • A multi-purpose, multi-room, multi-surface daily disinfectant

Download case studies of global pharmaceutical partners that have updated their disinfection/decontamination protocols by integrating SteraMist™ BIT™. The newly validated SteraMist™ BIT™ procedures improved disinfection for materials transfer and whole room/multiple room disinfection.

Read more about how TOMI™ can support through all equipment validation and qualification steps.

Receive a custom evaluation and learn more about how to integrate the SteraMist™ Surface Unit or SteraMist™ Environment System into all disinfection protocols. 800-525-1698 or email info@tomimist.com.

 

 

*SteraMistTM Surface Unit: Staphylococcus aureus (Staphylococcus) (Staph) (ATCC# 6538), Pseudomonas aeruginosa (Pseudomonas) (ATCC# 15442), and Methicillin Resistant Staphylococcus aureus (MRSA) (ATCC# 33592)

**Influenza A (H1N1 virus)

┼SteraMistTM Environment System: Clostridium difficile spores (C. diff) (ATCC# 43598), Staphylococcus aureus (Staphylococcus) (Staph) (ATCC# 6538), and Pseudomonas aeruginosa (Pseudomonas) (ATCC# 15442)