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Guidance 095 Metal Detection Sample

This document provides guidance on the installation, use, and maintenance of metal detectors in pharmaceutical and animal health products that do not contain metal components. It outlines factors for determining the need for routine metal detection, action levels for isolated units, and requirements for installation qualification (IQ) and operational qualification (OQ) of metal detectors. Additionally, it emphasizes the importance of sensitivity settings, preventive maintenance, and in-line challenge tests to ensure effective metal detection.

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8 views

Guidance 095 Metal Detection Sample

This document provides guidance on the installation, use, and maintenance of metal detectors in pharmaceutical and animal health products that do not contain metal components. It outlines factors for determining the need for routine metal detection, action levels for isolated units, and requirements for installation qualification (IQ) and operational qualification (OQ) of metal detectors. Additionally, it emphasizes the importance of sensitivity settings, preventive maintenance, and in-line challenge tests to ensure effective metal detection.

Uploaded by

katrinajasper
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Title: Metal Detection

Guidance Number: 95
Prepared by: Date: Supersedes:
Checked by: Date: Date Issued:
Approved by: Date: Review Date:

Introduction
This document provides guidance in the installation, use and maintenance of metal detectors
in Pharmaceutical and Animal Health solid oral dosage form drug products and medical
devices that by design do not contain metal components.

1. Definitions – the following terms apply specifically to metal detection as used in this
guidance.
Rotonoid – double acting electrical solenoid valve that is electrically controlled in two
directions (e.g., open and closed) with no spring return.

2. Site quality team’s decision on whether routine metal detection operations are required for
products at their Site should be based on, and not limited to, the following factors:

- Product history of metal contamination incidents (e.g., equipment failures,


equipment metal-to-metal contact causing contamination, raw materials with
metal contaminants);

- Assessment of manufacturing and/or packaging processes involved in terms of


possible metal contamination

- Effectiveness of the metal prevention systems and processes used at the site; and

- Commitments to Regulatory Authorities.

3. Action Levels for the total number of units (e.g., tablets, capsules, bottles) isolated by the
metal detector should be developed by the quality team based on and not limited
to:
- Historical data on the number of units contaminated with metal according to
product and/or manufacturing or packaging process step;

- Investigation reports [e.g., Deviation Reports] including any documented product


recovery from contaminated units; and

- Applicable quantitative results indicating that preventive measures have reduced


metal contamination in manufacturing and/or packaging process steps. Such
preventive measures include and are not limited to:
· Installation of rare earth magnets at raw material charging stations;
· Raw material process improvements by the vendor that reduced
contamination; and
· Manufacturing or packaging equipment set-up improvements that
reduced contamination resulting from equipment wear.

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Guidance 095 Metal Detection

not limited to:


· Reject gate reaction time, if reject gates are present;
· Length of time reject gate stays open;
· Throughput process speed; and
· Sensitivity settings.
11. Metal Detector IQ should include, and is not limited to, verification and documentation
that:
- Metal detector is installed according to specifications;
- Utilities (e.g., electrical, air supply) are identified and the direction of flow
indicated when necessary; and
- Routine preventive maintenance measures are established.

12. Metal Detector OQ should include, and is not limited to:


- Alarm tests;
- Test for radio frequency interference;
- Challenge metal detectors used in manufacturing operations with discs/cylinders
containing spherical 0.5mm ferrous, 0.5mm non-ferrous, and 0.8mm stainless
steel metal;
- Challenge metal detectors used in packaging operations with discs/cylinders
containing spherical 1.0mm ferrous, 1.0mm non-ferrous, and 1.5mm stainless
steel metal;
- The above challenge tests should be performed with the manufacturing or
packaging process performing at its maximum validated throughput rate;
- Sensitivity settings for each product or group of products with the same product
signal noise are established;
- Reject gate reaction and delay time for each product or group of products with the
same product signal noise is established; and
- Length of time that reject gate stays open is established.

13. The Metal Detector Sensitivity Settings should be verified and documented by a
qualified operator during the set-up operation.

14. Metal Detection Equipment Set-Up and Operating Parameters for each product or
process combination should include, and are not limited to:
- Clean and dust-free environment during set-up;
- Correct sensitivity settings for each product or product group;
- The reject gate reaction and delay time, when a reject gate is used;
- Length of time reject gate stays open;
- Throughput speed; and
- Correct chute and chute alignment for aperture size.

15. In-Line Metal Detector Challenges should be conducted with the process equipment
running. Each challenge should consist of three passes of the challenge disc/cylinder
through the aperture. Such in-process challenge tests should be performed and
documented, at a minimum, as follows:
- Lot/batch start-up;
- After re-starting equipment (e.g., after breaks, shift changes, or downtime
exceeding two hours); and
- At the end of a batch/lot.

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