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Home Product Inspection Equipment Product Quality Inspection for the Pharmaceutical Industry

Quality Inspection for the Pharmaceutical Industry

Advanced quality inspection solutions support pharma, biopharma, and medical device manufacturers for physical contamination detection, fill level control, package integrity and completeness checks.

Tackle the product and quality inspection challenges facing pharmaceutical manufacturers - including rising cost pressures, increased production complexity and faster time-to-market requirements - without compromising on safety, quality, and regulatory compliance.

Pharmaceutical Quality Inspection

What levels of sensitivity can pharmaceutical metal detectors reliably work to?

First, for the most accurate answer to the level of sensitivity you can expect from your metal detector in pharma and biopharma products, you need to consider:

  • The type of product being inspected
  • The aperture size of the metal detector being used

Our pharmaceutical metal detectors can detect calibrated and validated spherical samples of stainless steel down to 0.3 millimeters in diameter, and even smaller samples of ferrous and non-ferrous metals.

What validation documentation is available with your metal detectors to assist with pharmaceutical due diligence?

Prior to shipment of your METTLER TOLEDO Safeline metal detection equipment, we can supply a Design Qualification (DQ) pack for the system. After your equipment is shipped, we can supply an Equipment Qualification (EQ) pack, which includes protocols for:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Investing in annual Performance Validation Service can support your validation processes through independent testing and subsequent certification. 

Can pharmaceutical metal detectors detect difficult-to-see metal contamination such as very small and thin wires?

Yes, pharmaceutical metal detectors do have the capability of detecting small or thin metal wire pieces. The actual size (in length and diameter) of wire that is detectable depends on the spherical operating sensitivity of the metal detector and the orientation of the wire as it passes through the aperture of the metal detector.

To achieve the best detection levels for metal wire contamination, you must operate the metal detector at the best possible spherical sensitivity level for the application. In other words, the metal detection settings should not be so sensitive that it triggers false positives, but they should be sensitive enough to reliably detect very small and thin wires.

An experienced metal detection equipment provider can help you find a metal detector with the capabilities you need for your individual application requirements.

detecting small wires in pharmaceuticals

How can a checkweigher help to avoid recalls in the pharma industry?

Pharmaceutical products are required to include instructions for use and any applicable health warnings in order to comply with regulations. Should this insert be missing from the package, it can trigger expensive product recalls - as well as fines. Our highly accurate pharmaceutical checkweighers can detect the small weight difference between a package that contains the required documentation (such as a leaflet detailing proper use, active ingredients, and health warnings) and a package which is missing this vital information.

This simple due diligence check helps to prevent customer safety issues and costly recalls that result from pharmaceutical products going to market without these critical components.

How can a pharma checkweigher optimize efficiency in pharmaceutical production lines?

METTLER TOLEDO pharmaceutical checkweighers help prevent downstream issues in the production line - which can happen due to improper product spacing - by using product handling tools designed to support smooth transportation while maintaining the correct distance between pharma products on the line.

In addition, pharma checkweighers can help prevent lost production time due to askew packages causing stops on the conveyor line by automatically rejecting the misaligned package from the flow before it has a chance to become a problem.

Do x-rays affect the quality and efficacy of a drug during product inspection?

pharmaceutical x-ray inspection

The type of x-rays used for x-ray inspection of pharmaceutical products are not generated from naturally occurring radioactive materials. Instead, they are man-made and generated within the inspection equipment itself. Similar to an electric light bulb, they can be turned on and off at will. When following the proper use and maintenance routines, they are as safe as any other equipment found in pharma manufacturing sites.

In pharmaceutical inspection, the level of x-ray exposure is generally much lower when compared to other sources of radiation such as medical x-rays, security scanning, food irradiation or even everyday naturally occurring background radiation. This is because in pharma x-ray inspection, the x-ray energy used is low, the quantity of x-rays used is minimal, and the exposure time is very short.

Are your pharma inspection products GMP Compliant, especially for the application case 21 CFR Part 11?

Yes, METTLER TOLEDO product and quality inspection systems are fully compliant under Good Manufacturing Practices (GMP) for proper procedures for quality control in the pharmaceutical industry. 

How do you support pharmaceutical guidelines of data integrity?

The reliability and integrity of pharmaceutical data is fundamental to regulatory compliance and patient safety. Solutions from METTLER TOLEDO can help to make sure that documentation is complete, accurate and traceable. For example, our pharmaceutical checkweighers offer password-protected user profiles and local audit trail options to record all implemented system changes, aiding in easier auditing of production processes. 

Explore more METTLER TOLEDO solutions and how they can be implemented to improve processes - from lab to production.

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