Microbial contamination could consist of bacteria, fungi, viruses or bacterial spores. Many biocidal disinfectants have a broad spectrum of activity, especially against bacteria and fungi. However, most are not effective against bacterial spores, which pose a particular threat as they are so difficult to kill, and can lay dormant for extended periods of time.
Certain disinfectants that are effective against spores can be so aggressive that they may also be harmful to health or equipment, and are therefore not most suitable for frequent use, so choosing the right product for your critical environment is essential.
Is the biocidal disinfectant cleanroom compatible?
It is essential that the disinfectants used to remove contamination do not bring contamination into the cleanroom environment. GMP requires that disinfectants used in Grade A and B areas, such as an isolator or laminar flow cabinet, should be sterile prior to use. GMP also states that where disinfectants are used more than one should be employed.
Cleanroomshop offers a range of rotational disinfectants, designed to effectively control all types of microbial contamination in cleanrooms. Cleanroom processed, they ready-to-use or concentrated, they are available as either spray systems fitted with the SteriShield Delivery System, which ensures the sterility of the contents is preserved throughout use, or in a 5 litre capped container.
Our shop team are on hand to discuss all the different options to help you choose the right product for your requirements.
What is the contact time?
Contact times provided on our full range of biocidal products should be used as a guide only, as current GMP guidance suggests that contact times should be revalidated in each facility as they can be affected by surfaces, temperature and air change rate.
Will the biocide leave a residue?
Wherever biocides are used then residue will exist. It is important to understand the amount of residual biocide remaining on a surface, so that effective removal methods can be adopted.
Where air changes are high within a cleanroom, aqueous disinfectants dry quickly. Residues can mean continued antimicrobial activity; however, residues can be sticky, trapping dirt and debris and inactivating other disinfectants. If not addressed, this residue can have an impact on your cleanroom integrity.
Key points for addressing residue are:
- Select a biocide with a low concentration, but high efficacy
- Regularly remove residue with a detergent before and/or after using the biocide
- Alcohol can be used to remove residues after the planned cleaning activities
- Highly purified water or WFI can be used to remove residues after the planned cleaning activities
- Ensure that the wet contact time is observed
- Always ensure that surfaces are dry prior to starting cleanroom activities
Does it comply with regulatory issues?
The Biocidal Products Regulation (BPR) aims to ensure a high level of protection for humans and the environment.
It is a requirement for biocides to be registered with the European Chemicals Agency (EHCA) and products must be labelled in accordance with the Classification Labelling and Packaging Regulation (CLP).
All manufacturers of active substances must be included on the Article 95 alternative suppliers of active substance list. The list is ordered by active substance and under each ingredient is a list of the manufacturers that have met the regulatory requirements. Put simply, if the manufacturer is not on the list, they are not permitted to produce the cleaning solutions with that active ingredient.
Is the biocide safe to dispose of?
If you use biocides, it is your responsibility to ensure that any biocidal waste is disposed of properly. Check the label for advice on disposal of the product or empty container. You will need to identify safe methods for disposing of surplus biocides and the empty container, which may involve contacting a specialist waste contractor.
What is the importance of Biocide Rotation?
The frequency of biocide rotation – switching the base chemical – is borne out of evaluating environmental monitoring. Environmental monitoring data should be reviewed for microbial trends, allowing frequency of cleaning and disinfection to be based on risk. Understanding how your cleanroom is performing, the type of activities undertaken in the cleanroom and the number of operators within the cleanroom will all have an effect on the extent of controls required. Undertaking a risk assessment to determine the operating conditions of your cleanroom is the first step. This assessment will assist in identifying the measures that need to be applied for adequate rotation.
Key points to consider are:
- Assess the operating conditions
- Understand actual microbial data
- Always rotate the base chemical
- Always incorporate sporicides in rotation
- Start with higher requirements, assess microbial data for a set period and realign cleaning requirements after evidence of successful periods of control.
For furthur information on our range of biocides and other hard surface disinfectants, contact a member of our team. We will be happy to help.