MHRA Guidance supports SteriShield Delivery System

Ecolab Contamination Control has welcomed recently published guidance from the MHRA regarding dispensing systems for disinfectants in cleanrooms.

It emphasises the need to reduce the potential for contamination of the contents during preparation and manufacture by using a protective closed system, defined as one which is not exposed to the atmosphere.

The guidance further states that dispensing systems should also minimise the potential for contamination of the supplied contents as the unit is used, typically this involves a bag in bottle or some other mechanism to prevent ‘suck back’.

James Tucker, Marketing Director at Ecolab Contamination Control says the guidance validates the firm’s own unique SteriShield Delivery System: ‘We are delighted that the MHRA has clearly stated the need for a fully closed system to prevent air entering the bottle and recognise it is essential that the integrity of the product is also completely protected throughout its entire use, and not simply at the manufacturing stage.  This definition is therefore clearly applicable to the guidance for trigger spays as well.

‘Research has proved that conventional trigger sprays used with cleanroom disinfectants ‘suck back’ air, meaning the contents of the bottle can be contaminated from the first moment of use, leading to a spread of contamination around the cleanroom.

‘We believe our system is the only validated protected closed trigger spray system on the market and delivers fully in accordance with the recommendations of the MHRA.’                                                                                                                    

The system developed by Ecolab Contamination Control ensures that the trigger spray operates as a closed system due to the vacuum created in use, with the dip tube providing the only point of entry into the bag of sterile liquid. The patented and unique way the trigger head works forms a complete seal, preventing any air being drawn into the bottle.                                                 

Unique vacuum and particulate testing has been undertaken which has proved that the trigger and bottle combination creates and maintains a closed system which protects the sterility of the contents indefinitely, with a recommended best practice of in use shelf life of three months.

Mr Tucker says that the guidance issued by the MHRA should force other organisations to review their guidelines relating to trigger spray systems, which could have far reaching consequences. ‘It is highly likely that there will be a unilateral shift to closed systems to eradicate any possibility of content contamination, which puts us very much at the forefront of the industry.’