This is a great question and a great topic of discussion. I will provide my input for the extrusion area / material and perhaps you may find it useful or at the very least informative.
Raw materials - Biological Risk
What steps are you taking to reduce the likelihood of that hazard?
- Supplier Approval Program:
`Provide supplier with a survey that addresses (Transportation & Distribution, Controls of Operations, General Programs, Manufacturing Facility & Equipment, Facility Maintenance, GMPs & Sanitation) Complete the survey for each manufacturing site that supplies a raw material to your facility. This must be refreshed on an annual basis
`Require a letter of guarantee from supplier of raw materials
`Request a copy of any certifications they may have (ISO, BRC...)
`Require compliance letters and information from supplier regarding the raw material and its compliance with various 21 CFR articles (General Indirect Food Additives (21 CFR 174), Adhesives and Components of Coatings (21 CFR 175), Paper and Paperboard Components (21 CFR 176), Polymers (21 CFR 177), Adjuvants, Production Aids, and Sanitizers (21 CFR 178), Irradiation in the Production, Processing and Handling of Food (21 CFR 179) and of course 21 CFR 110
`Test run of my material to evaluate chemical and physical properties
`Maintaining a relationship with supplier
`Inspect each incoming load of the material
-Handling/Storage of the raw materials:
`Does your facility have automatic lines that feed into your hoppers? If so, that would be ideal. There's no extra handling that could potentially introduce any potential contaminant. This would also be applicable for the storage of that raw material.
`Processing the material requires extremely high temperatures =or> than 350 degrees which is not suitable for the growth or maintenance of microorganisms
`Create a program to evaluate microbial growth in high risk areas in your facility (frequency: at least annually) - to demonstrate that your SSOPS are effective and that the finished product is not going to be compromised -these areas should include where the product come into direct contact, known microbial carriers like hilos, packaging areas, storage areas
`The implementation of a surrogate test such as ATP (while it will not tell us whether whats found is microbial we can understand that it's related but not correlated based of the amount of organic material found)
`Demonstrate history of such issues
All of the points above then need to be evaluated on a risk analysis assessment to demonstrate how each of these things controls the possible risk.
Let me know what you think!