Online Pharmaceutical Product Inspection FAQs

A: Online product inspection encompasses a range of techniques to test raw materials, finished and packaged products for correct weight, completeness and freedom from foreign object contamination.  Thermo Fisher Scientific design and produce online checkweighing, x-ray inspection and metal detection systems specifically tailored to meet the needs of pharmaceutical producers.

A: The techniques are applied at multiple points – in tablet and capsule making, in bottle and vial filling, blistering, and primary and secondary packaging.

A: Pharmaceutical packages tend to be both small and light in weight. At today’s high production speeds a highly precise checkweigher is needed to ensure that packages are complete, for example, ensuring cartons contain product information leaflets and the correct number of blister packs. The Thermo Scientific Versa Rx is a system designed specifically to meet the unique requirements of the pharmaceutical industry.

A: Yes. Checkweighers can be integrated with other equipment and software to provide a complete track and trace solution. The Thermo Scientific range of pharmaceutical checkweighers have the flexibility of communications to be successfully integrated into such a system.

A: Pharmaceutical production environments are necessarily clean and highly regulated but foreign object contamination of final product can still occur. Potential contamination sources include raw materials, metal fragments from wearing of machinery such as tablet presses, and objects inside containers before filling.  Contamination can also come from damage to products during manufacture.

A: Metal detection systems designed specifically for pharmaceutical applications are available.  A typical foreign-object metal detector contains a transmitter coil (or coils) that sends out a radio-frequency signal.  Two receiver antennas are equally spaced to either side of the transmitter. The transmitter-receiver array is mounted around an aperture through which product will pass. When no magnetic or conductive materials are present inside the aperture the system is balanced and there is no difference between the signals at each receiver.  When metal travels through the aperture it creates a detectible imbalance, allowing for detection of metal contamination.

A:  Metal detectors are most commonly used to check capsules or tablets after filling and forming, either after tablet presses or dedusters. Other applications include checking of bulk powder ingredients in tubes and inspection of packaged, or part packaged, goods on conveyors.

A: A certain amount of flexibility is important to derive the most value from a pharmaceutical metal detection system. The Thermo Scientific APEX 500 Rx, for example, is fitted with wheels and handles so that it can be easily moved between production areas and cleaning areas. The system also has high levels of height and angle adjustability so that it can be quickly optimized for use on different pieces of production equipment as needed.

A: In some applications vision systems can be used, but contaminants in opaque products or containers cannot be inspected in this way. In such applications X-ray inspection is a powerful tool that can perform the required inspection.

Pharmaceutical X-ray inspection systems are based on comparing the density of the product and the contaminant. X-rays are very short wavelength, very high energy, light waves. As an X-ray penetrates an object it loses some of its energy. A dense area, such as a contaminant, will reduce the energy by a greater extent. As the X-ray exits the product, it reaches a sensor. The sensor then converts the energy signal into an image of the interior of the product. Foreign matter appears as a darker shade of grey and helps identify foreign contaminants. 

The same technique can be used to check fill levels and check packages for damage, or check for metal contamination in metal containing packages such as blister packs.

A:  X-ray inspection can be made of packaged pharmaceutical and nutraceutical products as well as empty packages prior to filling. Typical applications include detection of glass contaminants in glass vials for lyophilised product, inspection of ampoules, inspection of blister packs for missing or damaged tablets or capsules, and inspection of powders in metalized foil pouches or large tubs sealed with metalized foil (when traditional metal detector solutions are ineffective).

A: Work has been done to simulate the effects of X-ray exposure from inspection equipment on APIs but, given the number of different APIs produced, such work does not allow for a definitive answer to this question. It can be stated that the X-ray energies used and the total exposure levels during the inspection process are low and so unlikely to have an impact on API quality, effectivity or shelf-life. Should a specific product need inspecting, work can be done by system suppliers and producers to check whether a problem exists with that product.

A: Product inspection equipment is used in many industries and Thermo Fisher Scientific has a long history in serving these applications. Additional information on the techniques can be found in the following FAQs pages:

• Checkweighers
• X-ray Inspection
• Metal Detection and here