I just went through a relatively major effort along the same theme
regarding metal contaminant detection in solid dosage forms. I would also
be interested in hearing of any other approaches. In the mean time, here
is what I ended up establishing at our company:
The metal detection program is based on the USDA Food Safety and Inspection
Service (FSIS) Directive 7310.4 Rev. 2 dated 12-28-93. This is the closest
thing to a guideline that I was able to locate. The directive gives
policy, detection equipment and procedural guidance for the detection of
metal (and other foreign particle) contamination in food products.
Pertinent sections include:
IV. D. "The IIC (Inspector in Charge) may permit use of FSIS approved
equipment in conjunction with an approved PQC (Partial Quality Control)
program or a procedure approved for a specific incident to detect foreign
particles such as metal, plastic, rubber, or glass. The equipment used
must be capable of detecting particles as small as 1/32" (0.8mm) for
sorting and salvaging product..."
IV. F. "The use of a PQC salvage program is only allowed for occasional
accidental contamination incidents. Frequent or routine contamination
incidents indicate inadequate process control..."
VII. B. "Equipment used to re-examine product placed "on hold" by the
establishment for suspicion of particulate contamination must be capable of
detecting particles of 1/32" [0.31 inch (0.8mm)] in the greatest dimension.
Spheres of 1/32" [0.31 inch (0.8mm)] diameter are acceptable for use in
determining detection capability..."
VII C. and D. are also important as they specify the requirements for
testing the metal detector.
A key point in our policy is the definition of metal contamination. Our
policy for metal is that any particles rejected by our metal detectors are
considered contaminants. Any particles not picked up by our metal
detectors are considered trace amounts with no detrimental effect on the
We have 0.8mm 316L Stainless Steel standard spheres for setting up and
testing our detectors. Our detectors are set up at the lowest sensitivity
setting that will consistently reject the test spheres. This is in line
with our policy stated in the above paragraph.
Again, if there are any other guidelines or policies out there, I would be
interested in hearing them. Our position has been successfully presented
to our local district and it is base on current policy and solid technical
Geneva Pharmaceuticals, Inc.