Cleanroom Cleaning and Decontamination
The importance of cleanroom cleaning and decontamination in a variety of industry environments is paramount to ensuring the operational integrity of the cleanroom is maintained and cleanroom remains fully compliant.
Through its parent company CES are able to introduce the Micronclean Cleanroom Cleaning Service. The Micronclean cleaning team are a dedicated unit specially trained for environment decontamination. The service that they offer provides customers with:
- Assurance of environment compliance to GMP guidance and standards.
- Improved environment performance and reduced maintenance costs.
- An audit ready facility in time for external review & internal validation.
- Service reporting.
- Fully documented process for compliance with ISO9001 & 14001
The service is offered as a bespoke solution and serves a range of industries including:
- Medical Device
- Universities and Research
The cleanroom cleaning service is broken down into 3 distinct categories:
- Decontamination Cleans
- Routine/Regular Cleans
- Bespoke Cleans
Decontamination Cleanroom Cleaning
This level of clean can apply to any new cleanroom construction, a major spill or any clean that falls outside of the normal parameters of a regular or bespoke clean. It may also apply to post-shutdown cleaning and any decontamination after planned and/or emergency maintenance. This level of cleaning is designed to remove heavy bioburdens and large amounts of particulates. We provide all of our own fully certified equipment and consumables but can fall in line with your own procedures and materials where required.
We offer all stages of cleaning from vacuuming to cleaning of sensitive equipment in order to enable us to turn a new build into a fully functional, microbiologically in-specification facility. Product quality is further enhanced via Micronclean’s state-of-the-art storage facilities and own fleet of delivery vehicles enabling us to deliver right to the point of requirement.
Routine/Regular Cleanroom Cleaning
As the name implies, this category of clean is carried out at a regular interval whether weekly, bi-weekly, monthly, bi-monthly etc., and can be carried out within your own time parameters or those established after consultation as being appropriate for your needs. Regular cleans are designed to help maintain an already stable and fully functional facility. This type of clean is carried out in accordance with your own cleaning regime and methods and is designed to help maintain good practice within a cleanroom. Cleaning can be carried out in accordance with your own gowning and transfer methodology and all our staff are highly trained to provide the best quality clean of your facility
Bespoke Cleanroom Cleaning
We appreciate that every cleanroom and area has its own unique set of cleaning needs and requirements. To this end we offer a totally bespoke and tailored cleaning regime to all of our clients if required. Although we have recommended methods for each type of clean, we are completely flexible and are willing to work in conjunction with our clients in order to design and implement the best and most effective cleaning regimes. We can perform a full cleaning audit and work with you to establish any weak areas within your cleaning activities and implement steps to improve your practices. From materials and solutions used, regularity of cleaning, training of internal staff or supply of external staff, we can tailor cleaning schedules to any requirement. We work to our own Standard Operating Procedures (SOPs) and provide training records for all of our staff.
We can work alongside our clients to design bespoke SOPs that are specific for each job and enable you to have complete control over any cleaning activities that are carried out within your own facility. We are fully capable of carrying out any microbiological surface sampling that may be required before, during or after the cleaning. Contact plates can be carried out at our clients’ request in order to illustrate the effectiveness of our cleaning.
Quality Assurance/Cleaning SOPs
For each clean carried out, whether one-off or routine, a Clean Plan will be drawn up for approval. This document will include site plans and define the cleaning procedures and materials to be used. Creating sitespecific plans in this way provides flexibility, allowing consideration of individual customer requirements. Training All cleaning staff are trained to key GMP requirements. Staff training includes good hygiene practice, cleanroom gowning technique and cleanroom cleaning methods. Specific staff training requirements for customer sites will be considered during the planning phase of a clean.
On completion of a clean a Clean Record will be issued. The Clean Record contains a copy of the site Clean Plan, the results of pre- and post-clean environmental monitoring carried out, the batch information for all cleaning materials used and details of any deviations from the approved cleaning procedures, with a corrective action plan as appropriate.
Microbiological Testing Service (Pre/Post Clean).
We are able to offer microbiological testing pre- and post-clean in order to verify cleaning efficacy. Micronclean operate their own microbiological laboratory primarily servicing Micronclean production facilities. The laboratory is audited on a regular basis by customers from cleanroom industries including pharmaceutical and biotechnology, ensuring test systems remain in line with current best practice.
Disinfectant Testing (EN Norms)
Micronclean’s range of cleanroom disinfectants have been tested using European standard test methods. This testing has proven the broad-spectrum bactericidal and fungicidal efficacy of the agents used. Please contact our sales team for further information – click here. This testing has been supplemented by several years of experience successfully using these disinfectants in a wide variety of cleanroom environments.
Micronclean use 70% (v/v) aqueous solutions of isopropyl alcohol and denatured ethanol that meet the requirements of the European Pharmacopoeia. These solutions have been shown to give satisfactory disinfection test results using relevant European standard test methods – BS EN 1276:1997 (bactericidal suspension test), BS EN 1650:1998 (fungicidal suspension test) and BS EN 13697:2001 (bactericidal/fungicidal surface test).
All sterile cleaning and disinfection products in Micronclean’s Compliance 100® range have a validated shelf-life; this ensures products are sterile and effective at the point of use. The Clean Documentation provided allows traceability back to batch records of all products used, including records of product sterilisation.
For further information regarding the Micronclean Cleanroom Cleaning Service please contact our customer service department by email – click here.