Pharmaceutical Product Inspection Solutions for Quality Assurance and Regulatory Compliance

Prior to shipment of your METTLER TOLEDO metal detection equipment, we can provide User Requirement Specification (URS) support. After installation, Equipment Qualification documentation packages are available, including protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Periodic performance verification services can support ongoing qualification activities and help the system remain in a validated state throughout its lifecycle.

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.

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 quality assurance check helps to prevent patient safety issues and costly recalls that result from pharmaceutical products going to market without these critical components.

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.

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, pharmaceutical irradiation, or even everyday naturally occurring background radiation. This is because in pharmacutical 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.

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.

Secure user management, password-protected access, and audit trail functionality helps make sure that inspection data remains complete, consistent, and traceable in accordance with global data integrity expectations and ALCOA+ principles.

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

Pharmaceutical inspection systems must support important global pharmaceutical regulations including EU GMP (Annex 15), FDA cGMP requirements (21 CFR Part 211), and electronic records regulations such as 21 CFR Part 11 and EU GMP Annex 11. This requires features such as secure, audit-trailed electronic records, role-based user access controls, and the ability to demonstrate that systems are fit-for-purpose and maintained in a validated state. METTLER TOLEDO designs its hardware to meet these global standards.

For high-speed blister or carton lines, a tightly integrated combination of checkweighing and vision inspection is highly effective. For maximum contaminant detection in a small footprint, an x-ray system with integrated checkweighing capability is the premier choice. METTLER TOLEDO engineers these combination systems to deliver synchronized operation and a single data output point.