Cleanroom disinfection should rotate two biocidal products, one of which passes EN13704, with relevant EN certification and as short a contact time as possible.
This material is provided for general information purposes only and does not replace each user's responsibility to assess the operational, legal and other requirements applicable to each facility.
Maintaining a contamination-free cleanroom is crucial for the safe production of pharmaceutical products. Designing and following a validated cleaning protocol is paramount in ensuring that the integrity of the manufacturing environment is not compromised.
Detergents, disinfectants and sanitizers used in Grade A and Grade B production areas must be sterile before use. Additionally, multiple disinfectants should be validated for rotation to avoid microbial resistance, including at least one with sporicidal classification. A sporicidal disinfectant is required as many routine disinfectants are ineffective against spore-forming bacteria such as Bacillus subtilis.
Knowing which disinfectants are effective against which microbes is made easier by EN tests: European Standard microbiological test methods evaluate a product's effectiveness against different microorganisms, taking into account factors such as water hardness and organic soiling. The most relevant and commonly used EN tests for disinfectants for the pharmaceutical industry are:
EN 1276: A suspension test which assesses the product's bactericidal activity.
EN 1650: A suspension test which assesses a product's microbiological effectiveness against yeasts and moulds.
EN 13697: A surface test to assess the product's activity against bacteria, yeast and moulds on specific surfaces. This test was designed specifically for products used on hard surfaces to give a realistic test under in-use conditions.
EN 13704: A suspension test to assess a product's sporicidal activity.
EN 14476: A suspension test which assesses the product's virucidal activity.
Products tested according to the EN standards will provide the contact time required to achieve the level of kill stipulated by the standard. Contact time should also be given careful consideration when selecting a disinfectant. For example, certain products may meet the standard with a contact time of 15 or 30 minutes, but ensuring that a surface is kept wet for that duration can be very difficult due to the movement and air changes that occur within a cleanroom environment. This air movement tends to dry surfaces within 5 to 8 minutes, rendering the disinfectant action redundant.
The health and safety of cleaning and production operatives is another important factor in selecting a disinfectant product. Disinfectants can cause harm if misused, especially in industrial settings and at industrial strengths.
Any risks to human health should be clearly stated (damage to skin, damage to eyes, harmful by inhalation etc.) when the product is neat or diluted. If the product is to be diluted, the risk of incorrect procedure should also be described and any consequences e.g. release of poisonous gas, or corrosive working solution. This information can be found on the product information sheet, material safety data sheet (MSDS) and the product label.
As cleanrooms are regularly exposed to cleaning chemistry, it is essential that selected products are compatible with the production surfaces and do not cause any damage such as corrosion, scratches or pits. To be sure that production surfaces are in the best condition, chemical passivation should be performed regularly.
| Product Type | Antimicrobial Action | Sporicidal Action | Safety | Surface Compatibility |
|---|---|---|---|---|
| Isopropyl Alcohol (IPA) | Excellent | None | Good | Excellent - no known issues |
| Chlorine Dioxide | Excellent | Excellent | Excellent - no hazards | Good - safe to use on most surfaces |
| Peracetic Acid (PAA) and Hydrogen Peroxide Blend | Excellent | Excellent | Poor - emits powerful smelling vapour | Poor - has been known to damage metal |
| Amphoteric based | Good | Limited | Excellent - no hazards | Excellent - no known issues |
| Quaternary Ammonium Compounds (QAC's or Quats) | Good | None | Good | Good - safe to use on most surfaces |
| Biguanide Based Disinfectants | Good | Limited | Excellent - no hazards | Poor - can cause staining |
| Formaldehyde / Glutaraldehyde Based | Good | Good | Poor - can be very hazardous to human health | Good |
Taking into account the main consideration factors above, the ideal products for cleanroom disinfection would be two rotational biocides (one of which passes EN13704) with relevant EN certification and as short a contact time as possible.
The products listed below from our ClearKlens range have been formulated specifically for use in high-care environments and are available in sterile packs.
| Cleaning Step | ClearKlens Products | EN 1276 | EN 1650 | EN 13697 | EN 13704 | EN 14476 |
|---|---|---|---|---|---|---|
| Daily Disinfectant | ClearKlens Cleanisald (quat-based) | ? | ? | ? | ||
| ClearKlens Tego 2000 (amphoteric based) | ? | ? | ? | |||
| Sporicidal Agent | ? | ? | ? | ? | ? | |
| ? | ? | ? | ? | ? | ||
| Sterile Detergent | ClearKlens Plus | |||||
| Residue removal | ClearKlens 70% IPA | ? | ? | ? | ? |
Find out more about Diversey's ClearKlens product portfolio for the Life Sciences or contact us directly for help and support with your cleaning protocols.
Please contact your Diversey representative to confirm local product range and availability products mentioned.