Pharma-Processing_BioPharma

Adhering to stringent disinfection/decontamination protocols reduces the risk of microbial and fungal contamination during pharmaceutical processing, ultimately helping to ensure a safe product for the end-user or patient. Accounts of negligent cleaning and disinfection processes confirm how dangerous a mishap can be to an unaware public. The New England Compounding Center (NECC) of Framingham, Massachusetts is one example of a facility that distributed contaminated medicine to hospitals across the US, sickening hundreds with fungal infections which resulted in fatalities.

Control of microbial contamination is required by the FDA’s Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals. Facilities must have appropriate written procedures designed to prevent harmful microorganisms in unsterile and sterile drug products. SteraMist™ powered by Binary Ionization Technology® (BIT™) is fully validated to comply with good manufacturing practice (GMP) standards and is easily incorporated into current cleaning procedures.

SteraMist™ BIT™ Does Not Contaminate the Environment with any Toxic By-Products

Replace Quaternary ammonia, chlorine dioxide, and other harsh dangerous chemicals as disinfection/decontamination solutions for a more effective and efficient option. SteraMist™ BIT™ works like a gas reaching surfaces and hard to reach areas that other disinfectants/decontaminants can’t, killing pathogenic bacteria*, and leaving the environment with only oxygen and humidity.

Two Distinctive Platforms

SteraMist™ Bit™ comes in two platforms to make whole room disinfection/decontamination easier and disinfection/decontamination of high touch surfaces faster.

SteraMist™ Surface Unit: a fully portable hand-held, point and spray disinfection/decontamination system with an application of five seconds per square foot and a seven-minute contact time to disinfect/decontaminate. The SteraMist™ Surface Unit is ideal for all surfaces, including:

  • High touch surfaces
  • Pharmaceutical processing equipment (i.e. freeze dryers, autoclaves, ovens, etc.)
  • Pharmaceutical fill lines between runs
  • Laboratory furniture
  • Materials during transfer in and out of aseptic processing areas & clean rooms
  • Surfaces after cleaning up spills & mishaps

SteraMist™ Environment System: this transportable remotely controlled whole room fogging system delivers fast cycles that achieve minimal down time during whole room disinfection. The room fogger works to disinfect/decontaminate microorganisms in even the most hard-to-reach spaces. The SteraMist™ Environment System is ideal for disinfecting/decontaminating:

  • Clean Rooms & Compounding Areas
  • HEPA filtration systems
  • Multiple rooms simultaneously (multiple treatment applicators per unit)
  • Buffer & Ante Areas
  • Equipment rooms

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)

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