Supplier moulding machine validation detergents and lubricants

We have sourced a new supplier for our applicator component.

The supplier is currently preparing protocols to validate the mould and moulding process.

As the customer we have asked to be an approver on the protocol (1. is this normal/required?).

The protocol documents some detergents and lubricants that are used on the moulding machine. 2. What would be typical acceptance criteria or customer specification for lubricants and detergents? 3. How should they be validated?

FYI the applicator is for a medical device; The applicators will be tested for bioburden later in the process.


A new standard, which is being talked about a lot in the industry is ISO 21469, the next step in lubricant manufacturer regulations. Lubricants used in the food, food-processing, cosmetics, pharmaceutical, and animal feeds industries are included within the scope of this ISO standard. Until now, a lubricant’s recipe and its intended use were the only items that were reviewed and regulated. However, the “ISO 21469 - Safety of machinery – Lubricants with incidental product contact – Hygiene requirements” - certification programme, is much more comprehensive. It specifies the hygiene requirements for the formulation, manufacture, use and handling of lubricants, which may come into contact with products during manufacturing or processing. The product certification process will involve formulation and label review, auditing, risk assessment, and product testing.

In spring 2006, this standard was published officially as an European and International standard. As part of the standards published by the official Technical Committees ISO/TC 199 “Safety of Machinery” and CEN/TC 114 “Safety of Machinery”, it should also be seen in connection with the machinery guidelines. Since the standard EN 1672-2 demands for technically unavoidable incidental product contact the usage of so called food-grade lubricants, they are now defined in ISO 21469.

New in ISO 21469 is that, apart from the ingredients listed in 21 CFR § 178.3570, further ingredients can be used on the condition that they have an official authorisation as food ingredients.