Fast moving pharma industries need to maximize product quality, protect the safety of their customers and meet regulatory requirements. Regulatory agencies like the Food and Drug Administration (FDA) and the United States Pharmacopoeia (USP) provide constantly evolving guidelines to evaluate contamination in pharmaceutical products. Initiatives such as quality by design (QbD) and process analytical technology (PAT) are at the forefront of efforts to obtain better and cleaner manufacturing environments and products.
Current pharmaceutical manufacturing processes have been undergoing a continuous automation aimed at increasing production volumes, raising quality and countering cost pressures. Even in a well-managed, automated and mechanized facility, the possibility of the product contamination with metal at some point in the production process is very probable.
Metal contaminants are classified as ferrous (magnetic), non-ferrous (highly conductive non-magnetic metals such as copper, aluminium, and brass), and non-magnetic stainless steel. Ferrous contaminants are the easiest to detect and 300 series stainless steel contaminants are the most difficult to locate because the material is not particularly conductive or magnetic.
The most common possible sources of contamination can be generally divided into three categories: a) ingredient contamination, b) mixing process errors and c) machinery failures. In order to locate and reject the products contaminated with such metal contaminants metal detectors are incorporated as a critical element of many processing lines and also play an important role in FDA recommended Hazard Analysis and critical control point (HACCP) programmes. Modern pharmaceutical metal detectors with better technology and numerous features make it possible to consider using them at several stages along a production line, not just near the end before the product is stored or shipped.
There are many criteria to take into account when selecting and evaluating metal-detection systems for pharmaceuticals like, cost-effectiveness, straight through product flow to prevent product damage, high sensitivity, productivity, ease to use, compliance with GMPs in 21 CFR parts 210 and 211 and with quality assurance test and audit check features to verify performance.
In order to prevent a metal contaminated product from reaching to the consumer or recall of the products by regulatory authorities a more systematic approach must be followed instead of just installing a piece of metal detection equipment into the production line. The goal must be to achieve a foolproof system which is capable of running at maximum sensitivity with no false reject activity. Also if any product is rejected it must be further tested to determine the source of contamination and corrective actions must be taken to prevent further occurrence of contamination.
Hence the pharmaceutical manufacturers in the market for metal detectors are getting a metal detection programme also from the metal detection equipment maker, which encompasses a quality inspection programme, complete validation programme, testing facilities, certified calibration programme and a complete IT reporting. Thus greatest changes in automated features and enhanced support services offered are seen by the pharmaceutical manufacturers.
According to Ray Spurgeon Jr., Eriez X-ray inspection division product manager, “Enhancement in metal detector software and coil configurations have resulted in modest improvements in sensitivities and the best sensitivities are realized in the pharmaceutical industry as very small apertures are used to scan tablets.” He concludes by predicting that the metal detection technology is mature and will offer little or no future improvement to sensitivity.
As per many experts in the field , metal detectors are reaching a plateau in terms of sensitivity or the ability to find smaller targets. However the metal detection equipment makers continue to make improvements by rolling out models with greater sensitivities which are extending the usefulness of these detection systems. Some of such metal detection equipment are described in this article.
Thermo Scientific APEX 500 Rx pharmaceutical metal detector systems provide the highest level of brand protection and pharmaceutical industry compliance, in the most demanding tablet and capsule production environments. It is completely mobile with lockable wheels and adjustable height/angle so users can easily incorporate it into batch oriented, flexible production systems. The detector is installed at the out feed of a tablet press or capsule filling system and automatically rejects product if < 0.5mm pieces of metal are detected. The system is easy to use, fail-safe and incorporates the patent pending multi-coil metal detection design, enabling high sensitivity and low false reject rates.
Safeline pharmaceutical metal detectors (a subsidiary of Mettler Toledo) can be fully integrated with leading tablet de-dusters and other production equipment. Tablex-PRO is available with side-divert or lift flap rejection systems for the inspection of tablets & capsules while Pharma GF-PRO is for the inspection of fine powders and granular products under gravity-fall conditions. These metal detectors utilize sophisticated software technology to provide the most advanced metal detection systems for the pharmaceutical industry. They also provide self-contained inspection systems for use with all tablets, capsules and pharmaceutical powders. These systems ensure compliance with regulatory requirements, validation and quantification of procedures.
Another metal detector system designed specifically to check tablets and capsule, Fortress Pharmaceutical Metal Detector (Phantom Series) utilizes the latest digital signal processing technology, offers full validation documentation and can run multiple search heads from a single microprocessor controller. This system meets the demanding quality standards and regulations required by the industry with its current GMP design and construction suited for FDA compliance. The unit can detect tiny metal contaminants in high speed product lines with a throughput of 30,000 tablets per minute. User-friendly features include effortless tablet press integration via the powered lift for height adjustment along with the adaptable angled head tilt.
The Loma Pharmaceutical Metal Detector provides class leading in-line metal detection which is manufactured from stainless steel throughout to provide a hygienic, easily cleaned inspection environment. It is suitable for all sorts of pills. The entire unit is designed on the principle of integral hardware, which means that no loose parts and tools are required for dismantling. All product contact parts are made from high grade plastic and mirrored stainless steel to give easy cleaning and no cross contamination. The compact unit takes up minimum system length and can be located before or after the de-duster. The gas strut allows the unit to be easily adjusted to any tablet press and the angle of the product chute can be adjusted by a quick release clamp. The Loma IQ² pharmaceutical metal detector has Loma’s unique Automatic Product Learn system. This metal detector can be automatically calibrated – even under production conditions when the product is constantly flowing through the detector.
Another highly sensitive, compact designed metal detector system which meets stringent FDA standards and accommodates space–restricted areas within tablet and encapsulation rooms is Eriez’ E-Z Tec® Pharmaceutical Gravity–Fed Metal Detector. It has been designed for the detection and removal of minute pieces of ferrous, non ferrous and stainless steel contaminants. Eriez’ pharmaceutical unit has been engineered with an adjustable sensing head and has one of the largest and easiest to clean product chutes in the industry to optimize efficiency. The adjustable support stand comes standard with castors and is manufactured from 304 stainless steel.
The R&D team of one of the world’s leading independent supplier of industrial metal detection equipment- LOCK- were handed a simple brief – design a product to set new standards for efficiency, product quality, GMP, traceability and compliance with existing and forthcoming regulatory requirements.
The Insight PH range of pharmaceutical metal detectors represents a significant advance in metal detection technology. Their new technology is the inclusion of multi-coil arrangements as compared with a single transmitter with two receivers, which improves the signal, viewed by receiver and can improve detection performance of the instrument by 20 per cent. Highly resistant to vibration, the Integrated Digital Search Head and sophisticated Optix detector management software enable the Insight PH to clearly display the detailed product profile needed to achieve perfect product set-ups using Lock’s unique DDS (Direct Digital Signal) vector diagram. This guarantees detection and rejection of minute metal fragments at throughputs of up to 30,000 units per minute, while maintaining high productivity and market leading sensitivity to all metals.
A number of metal detectors are used in the pharma industry mainly for inspecting tablets and capsules coming from the presses. A magnet could be conceived as a metal detector. But it won’t detect aluminium, brass, or stainless steel. Metal detector performance, however, is limited by metallized packaging. Hence the traditional magnets and advanced electromagnetic devices used for detecting metallic particles have been joined of late by X-rays, with emerging technologies on the horizon.
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