With a complex operation and regular product introductions, the ready-meal manufacturer wanted to ensure its recent investment in allergen cleaning validation and verification was delivering maximum efficiency in line with industry best practice.
They needed an experienced partner to carry out a thorough review – one that went beyond conventional lab testing services to provide detailed analytical insights that would drive positive change. RSSL’s unique capabilities, flexibility and proactive approach to cleaning validation sets us apart from other providers, making our expert team the natural choice to take this project forward.
Unlike many allergen testing service providers, RSSL adopted a consultative approach and used our considerable field experience to assess the client’s current practices and allergen risk analysis process.
This involved a visit to the site where multiple cleaning validations for a wide variety of allergens were being conducted and numerous rapid tests used as a verification tool.
Our consultants reviewed the background to the existing plan as well as its implementation in the context of resource efficiency and consumer safety.
Following this detailed review, RSSL consultants delivered a comprehensive report, detailing our findings and identifying clear areas for improvement. We further supported the business by providing practical suggestions for how our recommendations could be implemented across the site, while also recognising that the introduction of any new measures needed to be operationally feasible.
Our expertise focused on moving to a more targeted risk-based approach to cleaning validation and provided extensive expertise and guidance around allergen testing. This included an extensive review of target allergen selection involving:
We also reviewed the use of on-site rapid allergen tests and provided a corresponding validation service. This had not been done before, which meant the site had been relying on un-verified testing to demonstrate the efficacy of its cleaning practices.
We believe RSSL is the only contract research organisation (CRO) to provide this level of service in the allergen cleaning validation and verification space. Many other labs act solely as testing service providers, analysing samples they are given but typically offering little to no support for the broader validation process and risk-based inputs, such as defining acceptance criteria, selecting worst-case scenarios and advising on revalidation strategies - often leaving manufacturers to manage these complex expectations on their own.
In fact, there are plenty of ways RSSL stands out – both in terms of our client-centric approach and the scope of our analytical expertise and strategic knowledge:
Holistic support
From identifying the risk of ineffective cleaning to allergen selection, sampling design and test kit suitability, RSSL offers step-by-step consultative guidance that is tailored to each manufacturing environment. Our robust, science-led approach is in stark contrast to the transactional models offered by other labs, where tests are carried out without considering validation design or regulatory justification, potentially resulting in incomplete documentation or failure to meet audit expectations.
Thoughtful selection of target allergens
RSSL guides clients through a targeted allergen selection process, whereas many labs allow clients to pick allergens with far less strategic input. We use ELISA rather than PCR as a preference for cleaning validation because it gives a quantitative measurement of allergenic protein concentration. Our ‘worst case scenario’ is based on key factors such as high protein content, high recipe inclusion, cleaning difficulty, good ELISA test availability and clinical potency. Plus, we verify that the chosen allergen is compatible with test kits and validated methods.
Defined validation design: Pre- and post-clean testing
With RSSL, clients benefit from a clear and customised three-part validation design that gives equal weight to each stage:
So, while other labs may focus heavily on environmental sampling and omit or downplay the importance of product testing, RSSL ensures there are no evidence gaps and swabbing strategies don’t miss critical areas of concern.
Integration with cleaning verification tools
Some labs promote rapid test kits as a standalone solution rather than a verification tool and tend to rely on them, despite their limitations in sensitivity and matrix interference. This approach can give a false sense of security which is why RSSL takes a different view, recommending the use of rapid test kits as a verification tool to carry out routine checks on rinse waters and surface swab samples.
In practice, this structured approach meant that despite the complexity of the food manufacturer’s business, RSSL’s consultants were able to gain a representative understanding of the practices relating to allergen cleaning validation and verification across the whole site and make evidence-based recommendations for change.
Our guidance meant the client could take an informed approach, using best practice to conduct a more thorough validation while saving considerable resources, reduce dependence on rapid on-site verification tools and gain greater confidence in cleaning.
In other words, RSSL’s testing strategy delivered faster, more reliable results without compromising safety or compliance. Crucially, we helped our client collect robust evidence that showed cleaning protocols were successful in preventing allergen cross contamination, safeguarding consumer health and meeting regulatory requirements.
Whether you’re an ingredient supplier, manufacturer, retailer or food service operator, our complete food allergen management service ensures compliance with industry requirements, including Natasha’s Law helping you to protect consumers and your business.
