How Clean is Clean Enough?

Nov 08, 2016

(BioVap™ Bio-decontamination System)

Bio-decontamination 101

Chemistry / Biocidal Effect

Regulatory

“Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice” published by FDA in September 2004, within Appendix 1: Aseptic Processing Isolators explains the need for decontaminated surfaces:

“1. Surface Exposure

Decontamination procedures should ensure full exposure of all isolator surfaces to the chemical agent. The capability of a decontaminant to penetrate obstructed or covered surfaces is limited.”

“2. Efficacy

The decontamination method should render the inner surfaces of the isolator free of viable microorganisms. Multiple available vaporized agents are suitable for achieving decontamination…. Cycles should be developed with an appropriate margin of extra kill to provide confidence in robustness of the decontamination processes. Normally, a four- to six-log reduction can be justified depending on the application.”

“E. Filling Line Sterilization

Where decontamination methods are used to render certain product contact surfaces free of viable organisms, a minimum of a six-log reduction should be demonstrated using a suitable biological indicator.”

PIC/S Recommendation “Isolators used for Aseptic Processing and Sterility Testing”; Chapter “An expansion of the detailed points to be considered for the implementation of the principles to isolators subjected to a sporicidal process” collects 14 points for the sporicidal process. Point 9.4.1 mentions H2O2 bio-decontamination:

“…The agent selected for gas generation should be sporicidal. The agent used for gas generation or other means of application should be capable of rapidly killing bacterial endospores, fungal spores and vegetative microorganisms. … Peracetic acid, hydrogen peroxide and formaldehyde are used. …”

What is BioVap™?

Esco Pharma has developed an effective hydrogen peroxide based bio-decontamination system capable of achieving a 6-log reduction in bio-burden validated using stainless steel ribbons populated with Geobacillus stearothermophilus spores as biological indicators.

Science Behind the Process:

 

 

The Esco BioVap™ system is a process of atomizing the hydrogen peroxide sterilant creating a dry fog as it is injected into the space. This unique system (patent pending) creates a charge on the atomized droplets as it passes through the nozzle generating droplets of the sterilant to contain billions of reactive molecules to execute a microbial kill. Also, the mutual repulsion of the charged droplets contribute to the superior distribution of the sterilant. Due to the attraction to the uncharged surfaces, the droplets burst on impact and immediately start the sterilisation process.

The volume of sterilant used therefore is minimised and can be of less concentration unlike conventional vaporising systems.

This revolutionary bio-decontamination system is not affected by the temperature or relative humidity. Therefore, there is no requirement to pre-condition the space being bio-decontaminated which leads to reduced cycle.

Conventional Gaseous Systems

Pre-conditioning Gassing / Injection Dwell Aeration

Esco BioVap™ System

Gassing / Injection Dwell Aeration

Flexibility Features

Esco BioVap™ system is developed to be flexible enough to adapt to different requirements of customers and facilities, from cabinets and transfer hatches up to modular enclosures to isolators.

 

BioVap™ apt for Esco Isolators!

References:

http://www.gmpua.com/Equipment/Sterility/Isolator/Bio-DecontaminationH2O2.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf

https://www.picscheme.org/layout/document.php?id=158

For more information, visit our website, www.escopharma.com, or Meet us at these events:

Pharmtech Expo 2016

November 22 - 25

Crocus Expo IEC, Pavilion 2, Moscow, Russia

MENA Pharmaceutical Manufacturing Congress

November 29 - December 1

Le Meridien Jeddah, Jeddah, KSA

2016 ASHP Midyear Clinical Meeting and Exhibition

December 4 - 8

Mandalay Bay Convention Centre, Las Vegas, Nevada

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