EN 14347 certification is important for disinfectant manufacturers who aim to release their products in the European market. This standard makes sure that the tested products are proven to be effective against harmful bacteria. Manufacturers can gain customer’s trust in their products by meeting EN 14347 standard.

The EN 14347 standard specifies a test method for evaluating the sporicidal activity of disinfectant or antiseptic products intended to be used in various sectors such as pharmaceutical, medical, and food processing industries. It ensures that disinfectants and antiseptics are effective in inactivating these spores providing a quantitative measure of their sporicidal efficacy.  Manufacturers must ensure that the products which are claimed to possess sporicidal activity are compliant with these standards. This article explores the significance of EN 14347 in disinfectant manufacturing and effectiveness and practical tips for its integration into manufacturing processes.

Practical tips for implementing EN 14347 in disinfectant manufacturing

Implementing EN 14347 during the initial stages of product development is very important. This standard is a basic suspension test that evaluates the efficacy of a disinfectant under controlled conditions. It is important to test the product early in the development process to make sure that the product meets the regulatory standards. This helps in identifying potential issues regarding the efficacy of the product that can be resolved before full-scale production. 

Thorough knowledge of the standard 

Manufacturers should have a thorough knowledge of the standard. This includes understanding the testing methods specified by EN 14347 standard and the concept behind these methods. This can help manufacturers identify the issues in their manufacturing process to ensure compliance.

Integrate EN 14347 testing early in the product development process

Incorporate EN 14347 testing protocols early in your product development cycle. This can save significant time and resources by identifying and addressing potential compliance issues before they become ingrained in the product design or manufacturing process.

Document everything

Maintain records of all tests, results, and adjustments made during the disinfectant development process. Documentation not only supports regulatory compliance but also aids in troubleshooting future issues or making improvements to the product.

Regularly review and update compliance processes

Regulatory standards and requirements are updated regularly and it is important to review and update your compliance processes accordingly. This ensures ongoing compliance with EN 14347 and other relevant standards thus safeguarding your products market position.

Train your staff

Ensure that your staff is well informed about the importance of EN 14347 and how it impacts product quality. Regular training sessions can help maintain high compliance levels and develop a culture of quality and safety within the organization.

Quality control measures

Implementing strict quality control measures that specifically focus on compliance with EN 14347 is very important. This involves regular checking of the product during the manufacturing process to ensure that every batch of disinfectant meets the set standards.

Choose the right laboratory

For testing and certification, select a laboratory that is accredited to conduct EN 14347 testing. An accredited lab will not only ensure that the testing is done according to the standard but also add credibility to your products’ antimicrobial claims.

The role of antimicrobial testing labs

Testing labs evaluate the sporicidal activity of disinfectants. They ensure that the tested products meet the standards required for market release. Their expertise and resources are important for manufacturers who cannot conduct such specialized testing in-house.

Microbial Investigations Switzerland (MIS)  is at the forefront of offering comprehensive testing and validation services tailored to EN 14347. With state-of-the-art facilities and a team of experienced microbiologists, we are equipped to help our clients navigate the complexities of sporicidal efficacy testing. We provide accurate and reliable results while in compliance with regulatory standards.

To get a quote on EN 14347 or to know more about our testing facilities, contact our experts here. 

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