Axiom Biotek

Why Need of VHP (Vaporized Hydrogen Peroxide (VHP®) Technology)

	The germicidal properties of liquid Hydrogen Peroxide has been recognized for more than 100 years, and has been used extensively in food, beverage, Medical device and healthcare industry.
	However, liquid Hydrogen Peroxide requires high concentrations and long contact times to be sporicidal
	Liquid or aerosolozed formalin still used as traditional process
	Gas formed by heating or formalin to potassium permanganate crystals
	Pre & post cleaning requirements
	Use restricted in many EU markets in preference to other technologies
	Difficult to validate process.
	Facility normally evacuated (Downtime)
	Flammable
	Lack of published data on efficacy

Regulatory institutions Demanding a safe, validatable, and effective low temperature sterilization technology for aseptic and critical manufacturing processes. (Avoid potential cross-contamination)

New Health & safety initiatives to elimination toxic and hazardous fumigation systems e.g. Formaldehyde, ETO,Chlorine Dioxide, etc
(Health concerns, employee liability issues)

Increasing use of isolator technology for aseptic drug manufacture v traditional clean-room concept. Over 100 pharmaceutical installation worldwide using isolator technology which has improved product quality, reduced product contamination and operating costs.

Healthcare companies The ChemGARD^® incorporates a combination horizontal/vertical sash designed for energy savings, operator safety and convenience.

Medical Device companies investing in VHP as new low temperature sterilization technologies to replace ETO, formaldehyde and other processes (Plasma / Gamma).

Food & Beverage Filling companies moving towards ‘aseptic’ filling of drinks and low acid foods using Hydrogen Peroxide systems to maintain ‘aseptic’ environment.

In late 1980s American Sterilizer Company (now STERIS Corporation) discovered that hydrogen peroxide is more sporicidal in the vapor gas phase, at low concentrations, than the liquid phase.

Vaporized Hydrogen peroxide was registered as a sterilant by EPA in 1990, and VHP® sterilization products were developed for a variety of industrial applications.

VHP® Atmospheric Pressure Applications

Pharmaceutical Sterility Testing Applications

	Isolator Decontamination
	Sterile product testing
	Sterile material transfer (Autoclave Interface)

Pharmaceutical production Applications

	Pilot and Small Sterile Batch Production
	Aseptic’ Sterile Formulations
	High Speed ‘ aseptic’ Filling Lines
	Aseptic’ Form/Fill Seal production
	Syringe Filling production ( Vaccines)
	Medical Device Processing and Packing
	Nuclear Medicine processes
	Freeze Dryer Interface

Room/Chamber Decontamination

	Pass through Rooms and Hatches
	Equipment Decontamination
	Eggs for Vaccine Production

Laboratory Equipment Decontamination

	Biological Safety Cabinets
	IVC Animal cabinets
	Devices, Electrical, Electronic, PC’s

Healthcare Applications

	Equipment Decontamination
	Pharmacy ‘aseptic’ preparation of drugs

Miscellaneous Industrial Applications

	Foods (Nuts, Herbs and spices)
	Food (Low acid) & Beverage filling
	Bio-terrorism ( Contamination control)

VAPORISED HYDROGEN PEROXIDE BIO-DECONTAMINATION SYSTEM

STERIS invented and pioneered VHP technology in the mid-1980s and to date has sold more than 2500 VHP systems world-wide. In fact, there are significantly more validated applications of STERIS’ units in operation than those of all competitors’ products combined. STERIS offers the only system based on a patented closed-loop “dry process” – a decontamination process which provides consistent, reliable and repeatable results while avoiding condensation, thus minimizing the impact of hydrogen peroxide on sensitive materials and enhancing safe use of the process.

STERIS VHP systems are currently used in filling and sterility isolators, single-use packaged medical device sterilization, lab animal research facilities, pass-throughs, BSL2/3 labs, IVC, Isolators, Biological safety cabinets, ductwork and HEPA filter decontamination and diverse other applications. In response to acts of bio-terrorism (Anthrax attacks of October 2001), large buildings with volumes exceeding 1.4 million ft³ have been decontaminated. Due to its environmentally-friendly process, low toxicity and high level of efficacy, VHP has become the method of choice for low temperature decontamination.

Unique process that uses hydrogen peroxide vapor

STERIS is the only manufacturer of VHP products based on a patented process generating hydrogen peroxide solely as a vapor. All other manufacturers have loosely controlled vaporization processes that produce a visible spray of tiny droplets. Some actually involve placing spinning nozzles into a room or enclosure to enhance distribution since these droplets are much more difficult to disperse than a vapor.

The “dry process” avoids condensation : During a typical decontamination process, hydrogen peroxide gas levels of 200 to 1,500 parts per million (ppm) may be achieved. For those processes failing to regulate humidity and thus maintain hydrogen peroxide in the gas phase, condensation will occur in the cooler areas of an enclosure. Because 35% hydrogen peroxide condenses before water vapor it becomes concentrated. It condenses into a 75% aqueous solution – this equals 750,000 ppm, or 750 times the typical concentration in the gas phase. As condensation occurs, hydrogen peroxide levels in the gas phase drop precipitously and result in large variations in concentrations throughout an enclosure. Small droplets of condensate – also referred to as “micro-condensation” – are too large to pass through HEPA filters and can alter their flow characteristics. Condensate is strongly affected by gravity and is less efficient than a vapor passing through duct work.

The VHP cycle operates in a closed-loop configuration where the enclosure is subjected to four phases :

	Dehumidification - Reduction of relative humidity
	Condition - Rapid increase to desired hydrogen peroxide vapor concentration
	Bio-decontamination* - Maintenance of desired hydrogen peroxide vapor concentration
	Aeration - Rapid reduction of hydrogen peroxide vapor.

Cycle times vary with initial temperature and humidity; enclosure type, size and configuration; and load. The process is fully automated. All cycle parameters are monitored and recorded for process validation.

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