EN 14347 is a phase 1 suspension test which evaluates the sporicidal activity of disinfectants and antiseptics. It provides a preliminary evaluation to ensure that the product is effective against specific bacteria under defined conditions. This test forms the base for more specific testing phases that follow.
Understanding and meeting the EN 14347 standards is important for manufacturers who aim to demonstrate the efficacy and reliability of their disinfectant products. The initial phase of testing serves not only as a regulatory requirement but also as a fundamental step in the development of an effective disinfectant product.
The importance of EN 14347 test
Evaluation of efficacy of the disinfectant using EN 14347 standard is important for several reasons.
- It guarantees that the product has effective bactericidal activity under a controlled environment. This reassurance is important for consumer trust and regulatory approval.
- Passing this test can help smoothen the progress through more complex testing phases and market entry processes.
- Meeting compliance with EN 14347 helps the manufacturer to develop a better disinfectant thus maintaining the product’s integrity and strengthening its position in competitive markets where efficacy and safety are very important.
Overall, it aligns with public health objectives as it assures that the disinfectants are capable of reducing bacterial load, thereby preventing the spread of infectious diseases.
What strategic approaches can be used to ensure compliance with EN 14347?
Meeting compliance with EN 14347 standards requires a strategic approach which involves the development and testing of disinfectant products, a deep understanding of the regulatory aspects and the specific needs of the intended application fields. Some strategies for ensuring that the products meet the requirements set by EN 14347 standards are:
1. Understanding the standard:
Start by thoroughly analyzing the EN 14347 standard to fully understand the scope, test conditions and requirements. This includes the specific conditions under which sporicidal activity is evaluated, the types of bacterial spores, temperature conditions, contact time and the required log reduction in viability as the passing criteria.
2. Formulating and optimizing the product:
- Targeted formulation
While developing formulations for disinfectants, manufacturers must focus on the sporicidal efficacy of the products against specific bacterial spores specified in the standard. This includes selecting active ingredients which are known to possess sporicidal activity and optimizing their concentrations and combinations to achieve the required efficacy levels.
- Adjusting the formulations
Results from initial tests can be used to improve the product. This can be done by adjusting the concentrations of active ingredients, pH levels and other formulation variables.
3. Conducting strict testing protocols:
- Internal testing
The sporicidal activity of the disinfectant products can be tested internally. This allows for rapid optimization before engaging in formal validation studies.
- Third-party validation
Partner with accredited laboratories to conduct formal efficacy testing. They provide a fair assessment of the product’s compliance with EN 14347 standard and help enhance credibility with regulatory bodies and customers.
4. Continuous monitoring and improvement:
Stay up-to-date with the changes in regulatory standards. This ensures ongoing compliance and may require reformulating products or adjusting testing protocols in response to new or revised standards.
5. Documentation and communication:
- Detailed documentation
Maintain detailed records of all testing data, formulation changes and compliance efforts. This documentation is important for regulatory submissions and can quicken the approval process.
- Transparent communication
Clearly communicate the product’s compliance with EN 14347 standards to the manufacturer so that appropriate measures may be taken for product improvement and development.
The importance of EN 14347 in product development
It is important to get EN 14347 certification for the disinfectant product during the development process. This certification guarantees compliance with European standards and also influences the strategy and outcome of product development in various ways:
- Enhances product efficacy
The testing protocols mentioned in EN 14347 guide manufacturers in enhancing their products to meet specific sporicidal activity requirements. This process helps in identifying and optimizing the active ingredients and formulations that are most effective against bacterial spores thus improving the overall efficacy of the product.
- Innovation and product development
The process of obtaining EN 14347 certification encourages innovation in product development. Manufacturers get motivated to explore new active ingredients, formulations and technologies that can meet or exceed the requirements of the standard. This can lead to the development of products that offer improved performance, safety and environmental sustainability.
- Confidence among users
By achieving EN 14347 certification, manufacturers can reassure users about the safety and effectiveness of the product. It provides healthcare professionals, veterinary practitioners and consumers with the confidence that the product they use has been tested and proven to be effective against harmful bacterial spores.
What is the role of microbiology testing partners?
Partners like Microbial Investigations Switzerland (MIS) play an important role in determining the antimicrobial performance of disinfectant formulations from the development phase through to the final product.
Our professional team provides expert guidance, testing services, and validation support which enables manufacturers to understand the complexities of compliance and product optimization effectively.
MIS offers comprehensive testing and validation services that adhere to EN 14347 standard. With our cutting-edge technologies and a team of dedicated professionals, we strive to provide accurate and reliable results to our clients.
To know more about EN 14347 testing protocols or to request a quote, contact our experts here.
