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Superbugs & Spores: As Featured in Cleanroom Technology

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Superbugs & Spores: GMP is More Important than Ever In Ensuring Quality Cleanroom Supplies.  

"As bacterial resistance grows exponentially alongside the increased use of antibiotics, so does the need for powerful cleaning agents. Traditional hospital disinfectants aren’t suitably advanced to defend patients against progressive ‘superbugs’ such as Fungal Meningitis and MRSA. Regardless of how thoroughly staff clean critical areas with traditional disinfectants, these ‘superbugs’ continue to thrive and spread."

The immunocompromised such as neonates and elderly patients are the common victims of these ‘superbugs’. Without the proper immune resistance, these particular demographics often lose the struggle against spore germination. With much attention in the healthcare industry upon spore-based infection, sporicides have become an increasingly hot topic and a must as part of routine contamination control.     

Spore-based infection can occur when bacteria like Clostridium and Bacillus form endospores in unfavourable conditions. When the cell undergoes dehydration it becomes surrounded by a three layered covering. The resulting structure (the endospore) is extremely tolerant to environmental conditions and external factors (e.g. disinfectants) and can remain viable for many years.

Bacterial spores are notoriously difficult to destroy due to their thick outer spore coats, tough inner spore coats and possibly even their abundance of exosporium proteins. Traditional alcohol-based disinfectants are completely ineffective against these types of spores.

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Sporicides however are designed to destroy spores on contact with a powerful application of chemicals that can penetrate the tough exterior of the spore coating. InSpec have developed two different formulations that can tackle these spores effectively with low residue and a short contact time. The first of which is a sterile preparation of hydrogen peroxide with peracetic acid, a formulation distributed as InSpec OX. InSpec OX is incredibly powerful, with a rapid action two minute kill time to EN sporicidal standards EN 14347. As one of the most effective known sporicides InSpec OX is used across the globe as part of a rotational pharmaceutical cleaning family, as well as for extensive use in cleanroom environments.

InSpec’s newest addition to the sporicidal armoury is a sterile sporicidal preparation of Hypochlorous Acid, a formulation distributed as InSpec HA.  InSpec HA was created to complement any rotational biocide system, providing critical performance without compromising the wellbeing of operators.  Without the proper implementation of complete disinfection programme incorporating biocides together with sporicides, healthcare-associated infections (HAIs) will not be fully addressed. The Centers for Disease Control and Prevention estimate that (HAIs) kill more people each year globally than car accidents, breast cancer or AIDS.

A sporicide such as InSpec HA is necessary to encourage the need for a more thorough and consistent use of sporicides.  InSpec produced this low-odour sporicidal preparation which is a fully effective sporicide (destroying spores to strict EN sporicidal standards, EN 14347) and can be handled far more safely than the more corrosive sporicides currently available to the industry.  The favourable chemistry of this Hypochlorous Acid at low chemical concentrations makes for an effective sporicide with a rapid wet contact time. Use of InSpec HA can be completed with the confidence that there will be no harsh odours or need for significant personal protective equipment (PPE).  InSpec HA’s low odour preparation leaves little residue in comparison to other sporicidal preparations on the market.   

Traditionally spraying and wiping as part of cleanroom hygiene maintenance has been carried out with alcohol-based disinfectants.  However, alcohol disinfection will not kill spores and has actually been reported to harbour them.  As a result, there have been several cases of spore outbreaks in cleanroom environments, including those in NHS run hospitals.  

The use of sporicides for spraying and wiping-in as a method for reducing and eliminating spore outbreaks within controlled environments is an increasing practice by many companies where contamination control is critical.  An increasing number of facilities are employing sporicide sprays and wipes into their product entry controls and rotational disinfection programmes to ensure that their cleanrooms are free of both fungal and bacterial spore activity.  Due to the success of this practice in reducing cleanroom spore presence, it is becoming widely speculated that spraying and wiping with sporicidal disinfectants is due to become accepted and normal practice for industry and hospitals.

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There has been a clear industry shift towards formalising and regimenting cleaning regimes as part of Good Manufacturing Processes (GMP) in the medical device and pharmaceutical industry. The expectance of formalising these processes as a basic standard are becoming increasingly apparent via reports from the Health Sciences Authority’s Updates on PIC/S and draft revisions of the GMP Standard.

The added value of industry manufacturers performing Quality Risk Management (QRM) of production systems is thought to be a more consistent use of GMP.  When integrated with Quality Management Systems, QRM is intended to enable and enhance compliance with regulatory requirements and science-based decisions. InSpec places a high value on quality management systems, with their Director of Operations and Quality Engineering Steve Brown (who is a member of the Chartered Quality Institute) holding decades of experience in this area. Steve Brown has been leading InSpec’s effort for implementing the gold standard of GMP for some years now.

It is important that industry embraces the QRM approach, and now looks more thoroughly into the available biocides, sporicides and packaging options to adopt systems that provide validated disinfectants and products that are compliant with current and future regulatory requirements. Requirements such as the Classifications, Labelling and Packaging (CLP) regulations and Biocide Product Regulations (BPR) which continue to impact the disinfectant industry.  InSpec’s Technical Manager, Marie Wright (who holds both a BSc and an MSc in Microbiology) utilises her excellent knowledge of good laboratory practice (GLP) during InSpec product development and manufacturing. As a result, all InSpec products go through extensive testing, and are only released once fully validated. The whole InSpec range passes all the appropriate EN standards EN1276, EN1650, EN13697 and EN13704, and all InSpec biocides are registered under the BPD (Biocidal Products Directive).

A recent independent study carried out an analysis of the efficacy of InSpec’s newest sporicidal formulation, InSpec HA. The results obtained demonstrated that InSpec HA provided a significant reduction against notorious Bacillus subtilis spores for the validated shelf life of 12 months. The reduction was meets the EN test efficacy requirements and is obtained in rapidly via wet contact time.

As business and organisations (such as the NHS) impose greater controls on spending, staff members are under the pressure to do more and to do it faster.  When wiping and spraying in, it’s easy to not fully saturate all of the wipe, or to use the spray inconsistently or unevenly - especially so when you’re having to do things quickly. Often, the preferred choice is to use pre-saturated alcohol wipes for this procedure.  Arguably pre-impregnated wipes are more convenient than using an alcohol sprays with a dry-wipe.   Pre-impregnated wipes offer a consistent amount of disinfectant per wipe.  This can speed up the spray/ wipe in procedure whilst retaining the efficacy of the procedure.

However, we know that alcohols do not destroy spores.   Until recently, a sporicidal spray and dry-wipes were the only option for a sporicidal cleanroom control process.  Most cleanroom sporicides are highly reactive oxidising chemicals; which is good if you want to kill spores but not so good if you want the most effective sporicides in convenient pre-impregnated session wipe or mops formats. The most common, highly absorbent wipe used in cleanrooms are blended cellulose/polyester fabrics.  Sporicides need to be strong oxidising agents that react readily with organic compounds, but consequently this means that frequently the sporicides and wipes react.  Pre-impregnated sporicide/wipe combinations are not compatible for prolonged periods of time as the sporicides activity is vastly reduced and the wipes substrate begin to breakdown.      

For the last year however, InSpec have been offering a unique solution for the issue of spraying and wiping into cleanrooms using sporicides. InSpec's Burstable Pouch technology (patent pending) offers same efficiency as a pre-impregnated wipes with the strength and power of a potent sporicide. The unique design of InSpec’s Burstable Pouches allows sporicidal solutions to be separated from the wipes by a frangible layer before use. This preserves the integrity of both the physical wipes, and that of the sporicidal solution.  To activate the wipes, pressure is applied to the Burstable Pouch.  The solution is forced against the frangible seal until the seal gives way and saturates the wipes with a precise volume of liquid. This method of point-of-use-saturation eliminates the chance of the sporicide degrading the wipes before use; providing the end user with much needed quality session wipes that can be used to efficiently wipe into cleanrooms and other controlled areas. 

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Recent developments with the Burstable Pouch have led to improvements with the pouch design and materials. To Improve the use of pouches in line with GMP and GLP practices, InSpec have eliminated the need for cutting equipment to open the pouches. New packaging advancements mean that the top layers of the pouch simply peel open to reveal the evenly saturated sporicidal wipes.  All of these newly designed InSpec Burstable Pouches now also come with the added value of containing 50% more wipes per packet.

 InSpec sterile sporicidal solutions HA and OX are available in Burstable Pouch wipe and Burstable Pouch mop format; as well as by traditional trigger sprays and large containers. These powerful solutions are making the most of new technologies in order to fight today’s superbugs and to eliminate spores from cleanrooms in hospitals and labs across the globe.