The Elements of an Effective Solid-Dosage Metal Detection Program - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Elements of an Effective Solid-Dosage Metal Detection Program
The author discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.


Pharmaceutical Technology
Volume 34, pp. S22-S25


Figure 3: AuditCheck (Thermo Fisher Scientific) block diagrams. The diagram on the left is a side view of the metal detector, displaying where the product and AuditCheck device passes through the electromagnetic field. The diagram on the right shows how the magnetic (X) and conductive (R) signals are calibrated with AuditCheck and how warning and alarm limits are set.
Quality control. One key consideration is how the detection system is audited. Typically, manufacturers audit detection systems every 1 to 2 hours during production to check for detection sensitivity (see Table I). Most of these audits involve simple pass/fail checks. An additional automatic early-warning system has been developed (Thermo Scientific AuditCheck) that can be set to periodically (i.e., based on user-defined preferences) pass a metal piece through the detector's fields to measure the two primary signals previously defined (X and R) (see Figure 3). These signals are calibrated during set-up, and any changes from the expected values can generate warnings or alarms to the user. An early warning allows the user to take immediate action such as cleaning the detector of foreign material or adjusting the detection threshold. As a result, production volume and time can be maximized. In addition, the automation of the audit can help to reduce labor resources.

Operation and deployment

After selecting and implementing a new or upgraded metal-detection system, a short on-line trial test is advised to further determine how the system is performing during production. In addition to the criteria outlined in Table II, one should consider the following:

1. Did the system reliably detect the metal sizes and types in question

2. Were there false rejects and, if so, why? Can they be avoided or minimized?

3. Did the system jam?

4. Can the system be adjusted easily to the production process with no loss of material?

5. Was set-up easy and how much operator intervention is needed to run the system?

6. How is the system audited and documented?

7. Can the system be cleaned easily? Can it be disassembled and reassembled quickly?

8. Did the system produce any errors? If so, how did it react?

Conclusion

Foreign-metal-object detection systems can help to prevent product contamination. Selecting a system requires a trial-and-error approach that takes into consideration the system's sensitivity, ease of use, and audit ability. Once implemented on a production scale, a metal-detection system can help to maximize product volume and quality.

Bob Ries is a lead product manager at Thermo Fisher Scientific, tel. 763.783.2500,
.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here