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OEM site assessments and inspections
Q: How can OEM site assessments and inspections help us optimize processes and comply with regulatory requirements?
imageThe significant increase in the use of highly potent active pharmaceutical ingredients (HPAPIs) and the push toward high-throughput processing and continuous manufacturing have impacted not only pharmaceutical manufacturing operations but also drug-product and worker safety. These developments have spurred changes in processing equipment, such as dust containment technology [1] and material transfer systems [2].
Despite the heavy emphasis that the industry places on continuing education, these changes can make it difficult for engineering and environmental health and safety (EHS) personnel to maintain their operational and safety knowledge as well as their familiarity with regulatory requirements. The sheer amount and variety of equipment in pharmaceutical manufacturing facilities today compounds this challenge. Even the most knowledgeable and experienced engineering and EHS professionals can still have questions about how to contain dangerous compounds across an entire production line, especially when that line is operating at a high speed.
The consequences of not having the right solutions on the line can be fatal. In the past, pharmaceutical companies have relied either on internal expertise or outside consulting firms for advisory services, but recently original equipment manufacturers (OEMs) have taken over responsibility for such services. This saves pharmaceutical companies time and money and also enables them to leverage their suppliers' deep industry knowledge. In particular, two additional touchpoints are becoming more common: site assessments and inspections.
Site assessments
A site assessment is an initial interaction during which an OEM visits a facility to better understand a pharmaceutical manufacturer's problem. OEMs know the different solutions available and the benefits of each. They have likely consulted at hundreds of facilities that run many different types of processes and can use their knowledge to take a holistic approach to a problem. If needed, they can also bring in other suppliers with complementary expertise to offer a more well-rounded and customized solution than customers would be able to find on their own.
This advisory process helps pharmaceutical manufacturers avoid expensive mistakes, such as purchasing equipment that fails to meet their specific needs. Also, as processes become more automated, manufacturers must be able to integrate new processing equipment. As my colleague Luca Di Siervi says, "Containment is not just the connection of different machines but also the integration of those machines into one system" [3].
An example is dust containment for HPAPIs. Individual process machines—such as tablet presses, capsule fillers, and blister packaging machines—can provide a high level of containment, but a major safety hazard could exist if the connections between those machines don't adequately control dust. The best way to keep your products and your workers safe is to enlist the help of experts who understand the process as a whole.
After-sale inspections by OEMs are becoming more popular as pharmaceutical companies seek to keep their lines running more efficiently while also complying with ever-evolving regulatory requirements.
For example, a tablet press, an encapsulation machine, a fluid-bed dryer, and a vacuum are just some of the pieces of equipment commonly found in production suites. These machines comprise small parts of a larger system and must work together with precision to perform their respective functions. As a system, they also sometimes run two, three, or even four shifts throughout the course of the day. The typical maintenance manager or technician is often responsible for up to 10 different types of equipment, each with its own nuances and intricacies. It's unreasonable to expect him or her to know all the particulars of each.
An OEM inspector will perform a nuts-and-bolts evaluation of a piece of equipment, including a status check for all parts and then make recommendations about maintenance, identify any possibilities for failure, and solve any issues that arise.
OEM inspections can also help you prepare for FDA inspections. Current good manufacturing practices (cGMPs) require extensive documentation—including details about equipment design and construction, cleaning and maintenance schedules, and inspection results—for every piece of equipment that comes into contact with a drug product [4]. An OEM partner can provide the necessary documentation and also make sure you're performing regular cleaning and maintenance appropriately so that your papers are in order when FDA inspectors arrive.
Selection of an OEM
Many OEMs offer site assessments and inspections. In addition to best-in-class equipment, find OEMs with the following characteristics.
Brand recognition. Despite its nearly one-trillion dollars net worth [5], the pharmaceutical industry is small. Solicit information about OEMs from the people in your facility and the industry at large. Your colleagues and counterparts can tell you which OEMs you can trust and which ones to avoid.
Industry connections. To help you solve big-picture problems, an OEM must be well-connected in the industry and able to bring in products and representatives from other companies when needed.
Free assessments, inspections, and training. Some companies charge a hefty fee for consultations, which typically indicates that the company doesn't have a direct sales force. To find the most cost-effective solution and ensure that consultants are easily accessible in the future, select an OEM with local representatives.
Having the right partners in your OEM network can save you time, money, and a lot of aggravation, stretching your equipment's value far beyond the initial cost of the equipment itself. Make sure you discuss the services, both before and after the initial purchase, that your potential partners can provide.
  1. Boris Pazovskiy. Dust containment technology. Solid Dose Digest. March 11, 2019. Accessed July 2019.
  2. Luca Di Siervi. Pneumatic transfer systems in continuous manufacturing. Solid Dose Digest. July 23, 2018. Accessed July 2019.
  3. Luca Di Siervi, Nilfisk. Is your dust containment equipment part of an integrated system? March 2018. Accessed July 2019.
  4. FDA. CFR Title 21, Part 211. Current good manufacturing practice for finished pharmaceuticals. Accessed July 2019.
  5. The Business Research Company. The growing pharmaceuticals market: Expert forecasts and analysis. May 2018. Accessed July 2019.

Boris Pazovskiy is business development manager for the pharmaceutical industry at Nilfisk, Morgantown, PA. The company manufactures industrial vacuum solutions, including vacuum cleaners, pneumatic conveyors, and dust containment systems.
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August 26, 2019
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