By Dr. Steve McAllister, Food Safety Professional

Packaging materials are not typically connected with biological, chemical, or physical recalls due to contamination. However, packaging manufacturers are expected to understand, apply, and validate their processes for consistency, quality, safety, and adherence to required methods and protocols.

According to the Food Safety Modernization Act (FSMA), the Current Good Manufacturing Practices (CGMP) regulations apply to the manufacturing of food packaging (see 21 CFR part 117, subpart B for more information). These regulations address, among other things, the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, and food-packaging materials with microorganisms, chemicals, filth, and other extraneous material.

Also, appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable (see 21 CFR § 117.80(a)(2)).

Through an inspection, packaging companies can quickly determine if they are following the expected protocols, which issues need to be addressed, and how to resolve them. These are the top five common issues I have recurrently encountered in packaging companies during my inspections.

  1. Hand washing facilities versus utensil washing facilities: in the packaging industry, it is very common to find sinks being used for both handwashing and utensil washing. Best industry practices include the separation and labeling of sinks to eliminate cross-contamination issues.
  2. Excessive lubrication: lubricants that are essential for effective equipment operations must be managed to ensure they do not get displaced onto food contact packaging. A lubrication program has proven to be effective. However, several factors, such as the right lubricant, in the right quantity, at the right time, at the right point, and with the right method, need be considered. Lubrication analysis, adjustments, contamination control, and inspections are among the main factors that contribute to an effective lubrication program.
  3. Utensil usage and storage: utensils are important tools used within the packaging environment. Inspections show that utensil-related issues have increased over time. All utensils should be approved and included in the facility program so that there are proper procedures for their inspection, use, storage, and handling. By taking these measures, contamination risks to products as well as product contact surfaces can be reduced.
  4. Gaps on dock levelers and dock doors: gaps on dock doors and dock door levelers could lead to pest access issues. To eliminate pest entry points, dock levelers and dock doors need to be made close-fitting or with a gap of less than ¼ inch or 6 mm, making them pest proof. The pest management program and inspections are used to address gap issues, ensure a safe packaging production environment, as well as to assess how well the facility implements and monitors programs.
  5. Temporary repairs: there are times when temporary repairs are necessary or unavoidable, but they should never be used as an excuse not to do permanent repairs. Issues with temporary repairs occur when they are not incorporated into a program (i.e., preventive maintenance, inspection). Procedures must be developed and implemented to define the type of material, required records, and timelines to ensure that they do not become a contamination risk to products or product contact surfaces.

If you work in the packaging industry, here are some other resources that might be useful to you:

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