With increasing episodes of adulterated medicines and food products coming to light in the recent days, many pharma and food processing companies in India have become more alert and are installing highly sophisticated and advanced metal detectors in their manufacturing lines.
The Indian pharma sector has come under sharp international focus with multiple regulators including the Australian and European agencies putting the country’s largest drug firm Ranbaxy Laboratories under the scanner.
Particularly the recent USFDA warning alerts to a large number of Indian pharmaceutical companies have become a concern for the Indian exports to the world markets.
Apart from Ranbaxy, other Indian pharma players including Strides Arcolabs, Aurobindo Pharma Ltd, Dr Reddy’s Laboratories Ltd, Wockhardt, RPG Life Sciences have all come under the USFDA lens for violation of manufacturing norms.
With India pharma today accounting for more than 10 per cent of the total US generic market, pegged at about $30 billion, no firm in the country wants to take a chance to lose the lucrative US market. With several home-grown players coming under the health sector watchdog’s lens, many of the manufacturing units, particularly the pharma, biotech and food processing units are now installing sophisticated metal detectors to ensure safety of the products.
“Thanks to the FDA recent crack down on the pharma and food processing units, the demand for metal detectors have grown double this year. For instance we had Rs four crore businesses last year; this year we are expecting Rs. eight crore business. Particularly the demand is more from food processing and of course the pharma firms though they are less preferring domestically manufactured metal detectors, but most of them prefer imported ones,” said Dattu Mali of Das electronics.
Briefing on the advanced packaging systems and processing systems installed with highly sophisticated metal detectors integrated in the processing lines, Abhijit Mukherjee, Chief Operating Officer at Dr. Reddy’s said, “ In pharmaceutical, quality and safety of the product is given utmost importance. Despite we being the leading cGMP and quality complier, USFDA and other regulators always look with an eye of suspicion and we do not give them any chance. We are pro-active and have installed highly sophisticated and well advanced equipment in our manufacturing units. We are even planning to embark on an automatic and robotic system to minimise the manual approach and reduce contamination as much as possible.”
Dr. Reddy’s Laboratories is the world's second largest producer of generic medicines from India. It has a capacity of wending nine billion tablets per annum. The manufacturing unit at Hyderabad is its largest facility with advanced technology and research and development happening at one campus at Bachupally.
Metal detector use in pharma industry
Metal detectors play a vital role in the safety of medicines. Be it in the processing lines or in the packaging lines, metal detectors are installed to detect any metal or foreign particle in the product that may cause contamination and ultimately affect the overall safety of the products.
For safety and quality, pharma and drug manufacturing firms need to install highly sophisticated metal detectors. Having metal detectors alone is not enough to ensure quality products, regular checking and cross checking of the performance of the equipment is of vital importance to obtain constant quality.
Particularly the manufactures of powder, solid or liquid products need to install highly sophisticated X-Ray metal detectors to have their product go through minute checks for foreign material.
During majority of investigations, the source of foreign particles in the drug product have found the following types of particles: metal particulates, coloured and transparent fibres (cotton and polyester), rubber like particles, and glass particles.
Despite many instances of such incidents many firms have shown reluctance in the past to implement corrective measures to reduce the foreign matter in final drug product. Clearly there is some negligence among the firms. All the pharma and biotech firms need to compulsorily install good metal detectors to achieve safety targets.
Enhancing safety and quality
Metal contamination may occur in food and pharmaceutical products due the presence of metallic pieces or components (viz fasteners, pins, buds, eroded or corroded metallic parts etc.) in ferrous, non-ferrous or stainless steel materials. Detection of such metal contamination is important and in this detection process, high accuracy and reliability are needed. Thus a metal detector plays an important role in ensuring product safety. Metal detector also protects equipment and regulates compliance in the food and pharmaceutical industries. Moreover, metal detectors play an important role in maintaining the organization’s reputation.
In many pharmaceutical processing, unsaturated organic compounds that contain double and or triple bonds need to be hydrogenated. Platinum black, palladium black, copper metal, copper oxide, nickel oxide, aluminium and other materials have subsequently been developed as hydrogenation catalysts. Abrasive materials can wear mill parts and screens. In these operations, a probability always exists the products get contaminated with various metallic components.
The final food and pharmaceutical products must be free from metal contamination as per GMP standards. Metal detectors are mostly used for US State Department of Agriculture (USDA), Hazard Analysis Critical Control Point (HACCP) or US Food and Drug Administration (USFDA) Certifications in India and other countries. Depending on the purpose, different types of metal detectors are available for checking metallic contamination in the food and pharmaceutical industries. For examining small and unpacked goods such as vegetables, snack items, frozen foods, sea foods, poultry and packed medicine conveyor type metal detectors are most suitable. Metal detectors with advanced microprocessor based technology are advantageous for checking coarse-grained food stuffs such as popcorn, cornflakes and soup noodles.
Types of metal detectors and their operation
Electromagnetic induction measurement
Using the electromagnetic induction measurement method, metallic elements on the food or pharmaceutical products can be easily detected. The operation of these metal detectors is based on the principles of electromagnetic induction. Metal detectors contain one or more inductor coils that are used to interact with metallic elements in the product.
Metallic contaminant in the product creates high frequency magnetic field within the detector coil, which in turn activates a reject flap by means of a solenoid. The detector is designed in such a way that it automatically removes the metal components form tablets without any interruption. The metallic contaminant is reliably rejected with very little loss of material due to the extremely fast and short activation of the reject flap of the detector. This type of metal detectors is mostly used to detect the presences of metal contamination in continuous tablets manufacturing process.
MFTR metal detector
MFTR metal detector works on the principle of multi-frequency transmission and receiving method. Multi-coil arrangements are used for the transmission and receiving of multi-frequency in metal detection. The multi-frequency created by the multi-coil arrangement improves the signal viewed by the receiver.
Compared with a single transmitter with two receivers, multi-coil arrangements can improve detection performance (as measured by the diameter of the metal sphere size that can be detected) of the instrument by up to 20 per cent.
Quality and integrity are the fundamental requirements for products from the pharmaceutical industry. Effective product protection is pivotal throughout manufacture and packaging in the pharmaceutical and food industries, for ethical pharmaceutical formulations, generic equivalents, or over-the-counter solid dosage products. Radio frequency signals Radio frequency metal detectors contain a transmitter antenna that produces radio frequency signals ranging from 300 kHz to 1 MHz.
Two receiver antennas sit on each side of the transmitter at equal distance from the transmitter. When the system is balanced and there is no magnetic or conductive inside the aperture of the metal detector, the difference of the two signals is zero, signifying that no metal is present.
When metal is present and travelling through the detector, a detectable imbalance is created.
VLF measurement
VLF measurement method metal detectors work based on the principle of Very Low Frequency (VLF) measurement principle. This method is most commonly used. The metal detectors contain two sets of coils, namely, transmitter coil and receiver coil. Electricity is passed through the transmitter coil to create a magnetic field. This constantly pushes the electricity into the ground and pulls it back up. The magnetic field so generated interacts with any metallic or conductive object that comes in its way and finally identifies the foreign particle in the product.