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Read the article:
The new Annex 1 regulations – why is it important and how can we help?
By David Keen
DIRECTOR, MICROBIOLOGY CONSULTING SERVICES AND VALIDATION
Annex 1 will impact on facilities and companies outside of the EU market. Find out how our global experts can help with your cleaning and disinfection options.
Our experts can help you achieve compliance with Annex 1* across six key areas in cleaning, disinfection and decontamination:
*Eudralex Vol. 4
Contamination Control Strategy (CCS)
Cleaning and disinfection is listed as a key element that should be included within the CCS. The strategy should detail the contamination risks, effectiveness of control measures and monitoring actions.
Ecolab provides a comprehensive Assessment Service enabling you to meet the Annex 1 CCS requirement.
“A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organisational) and monitoring measures employed to manage risks to medicinal product quality and safety.”
(Ref: EudraLex Vol.4 Annex 1 2.3)
Product Selection
Increased clarity has been provided on the types of agents needed with a distinction being placed on performing a cleaning step prior to disinfection, and highlighting the need for appropriate quality certification of the in-use products.
Made in cleanrooms, for cleanrooms, Ecolab’s range of contamination control solutions is designed to facilitate compliance with industry regulations.
“Disinfectants used in grade C and D may also be required to be sterile where determined in the CCS. Where the disinfectants and detergents are diluted / prepared by the sterile product manufacturer, this should be done in a manner to prevent contamination and they should be monitored for microbial contamination.”
(Ref: EudraLex Vol.4 Annex 1 4.35)
Residue Management
Disinfectant residues are to be managed using a risk based approach, focusing on their removal to ensure effective disinfection.
With our portfolio of low residue products and detailed technical data, Ecolab provides proactive support to help manage your risk from residues.
“Cleaning programmes should effectively remove disinfectant residues.”
(Ref: EudraLex Vol.4 Annex 1 4.33)
Disinfectant Rotation
More than one type of disinfectant is to be implemented within the facility, including the periodic use of a disinfectant effective against fungal and bacterial spores.
Ecolab designs bespoke cleaning and disinfection regimes to suit the contamination control needs of your facility.
“More than one type of disinfecting agent should be employed to ensure that where they have different modes of action, their combined usage is effective against bacteria and fungi. Disinfection should include the periodic use of a sporicidal agent.”
(Ref: EudraLex Vol.4 Annex 1 4.33)
Validation
There is a clear mandate to validate the disinfection process. Validation studies should demonstrate suitability and effectiveness of the disinfectant on the surfaces and in the manner in which they are used.
Easing the burden of validation, Ecolab’s team of Global Technical Consultants provides the resource and expertise to manage the challenges of disinfectant validation.
“Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used and on the type of surface material,”
(Ref: EudraLex Vol.4 Annex 1 4.34)
Education and Training
Personnel should have adequate training with specific focus on the principles involved in the protection of sterile product, including topics of cleaning, contamination control and microbiology.
A wide range of educational materials and hands-on training is available to assist with on-site learning needs.
“All personnel ...This training should include the basic elements of microbiology and hygiene, with a specific focus on cleanroom practices, contamination control, aseptic techniques...”
(Ref: EudraLex Vol.4 Annex 1 7.3)
Find out more about how Ecolab can help you build your roadmap to compliance: complete our Annex 1 enquiry form here
COMPLETE REQUEST FORMWhy has Annex 1 been updated?
Annex 1 has been modified to reflect the change in technology within the last 10 years, to harmonise with ICH chapters on Quality Risk Management and Pharmaceutical Quality system, and to provide greater clarity for interpretation of the content.
EudraLex Volume 4
EudraLex Volume 4 covers Good Manufacturing Practice (GMP) guidelines and Annex 1 is specific to the manufacture of sterile medicinal products.
Who are the Global Technical Consultants?
Our new GTC webinar series will cover all aspects of developing, building and maintaining your CCS as well as how Ecolab’s exclusive program can help you in easily refining your CCS for cleaning, disinfection & decontamination.
