Pharmaceutical manufacturers must meet industry standards
In any industry, it’s always important to have standards that lay out what consumers expect of the products created by manufacturers and define the processes by which these products can be created. Without standards, consumers may mistakenly purchase a subpar product that does not meet their expectations, leaves them frustrated and damages the manufacturer’s reputation.
In certain industries, compliance with these standards is absolutely critical. In any market where end users are coming in direct contact with a product or ingesting it – like the food and beverage, dairy or pharmaceutical industries – manufacturers must take every step possible to ensure the final product meets consumer expectations and is safe to consume.
To ensure that all products are high-quality, there are countless standards that govern many different industries. For example, fabricators of equipment for the dairy industry adhere to 3A standards, created in the 1920s to ensure that all machinery that came in contact with milk and milk-based products created a sanitary environment.
Pressing need for pharmaceutical standards
“With ASME-BPE, pharmaceutical manufacturers are better able to communicate their needs to equipment fabricators.”
Where the food and beverage, and dairy, excelled in having extensive rules and regulations regarding the environments in which products could be made, the pharmaceutical industry fell short. For many years, there was no 3A equivalent for biopharma manufacturers that explained what sorts of materials could be used to make equipment or how that equipment needed to be treated or maintained.
Manufacturers filled the void in their own ways. Some created their own in-house standards to ensure their products would always be consistent. Many turned to the dairy industry’s 3A standards and applied them to their pharmaceutical operations, Pharmaceutical Manufacturing explained.
Though sufficient to keep products sanitary, safe and consistent, the lack of a uniform standard weighed on the industry. After numerous requests, The American Society of Mechanical Engineers collaborated to come up with the ASME-BPE (Bioprocessing equipment) standard. ASME explained that this standard covers such important aspects as:
The standard was first published in 1997 and updated in 2002, 2005, 2009 and 2016, according to Pharmaceutical Technology. With it, pharmaceutical manufacturers are better able to communicate their needs to equipment fabricators, collaborate with other companies and stay in line with the U.S. Food and Drug Administration’s policies and current good manufacturing practices, Pharmaceutical Manufacturing explained.
Understanding your operation’s needs
It’s very likely that your operation has multiple systems and units for creating different products. Each one may have it’s own unique requirements and characteristics.
Every step in pharmaceutical production must be sanitary.
ASME-BPE is split into 10 parts, according to ASEPCO. They are:
- General requirements, which reviews all other standards and laws manufacturers must comply with when using pressurized equipment.
- Systems design, which speaks to bioburden control and cleanability across all process systems, components and utilities.
- Dimensions and tolerances for process components, which addresses topics like wall thickness, hygienic clamp unions, pressure ratings and more.
- Material joining, which speaks specifically to joining metallic materials at various points throughout the system, including acceptable discoloration at welded portions.
- Product contact surface finishes, which includes specifications regarding electropolishing and passivation.
- Sealing components, which addresses valves, seals and fittings. Both static seals, like o rings and hygienic unions, and dynamic seals, like dual mechanical seals and diaphragm valves, are highlighted in this section.
- Polymeric and nonmetallic materials, which goes into detail on compatibility and leachables.
- Metallic materials, which details various alloys, reviews different material types and covers very specific details like sulfur content requirements and ferrite levels in certain materials, like 316 stainless steel.
- Process instrumentation, which reviews instrumentation like temperature controls, flowmeters, pressure instruments and more. It also speaks directly to bioburden controls and cleanability.
- Certification, which outlines how a company can obtain its ASME-BPE certification, as well as which requirements could change. Tubing and fitting manufacturers primarily earn this distinction. Additionally, it’s important to note that, just because a piece of equipment was built according to ASME-BPE standards, doesn’t mean the fabricator has been certified by ASME. By working with professionals who have earned a certification through ASME, buyers have an added level of assurance that the product is top-notch.
Different parts of your operation will relate more closely to certain sections of the standards than others. For example, your high-sensitivity processes, those that require the strictest adherence to the standards and are often the ones that come in direct contact with the product itself, should be highly cleanable and able to be electropolished. Materials selection should be carefully thought-out, not only for interior surfaces, but exterior as well.
Low-sensitivity processes, on the other hand, won’t come in contact with the product but rather support those systems that do. They, therefore, must also be carefully fabricated to ensure a sanitary environment, but don’t need to be as high-grade as the processes that directly touch the final product, such as tank jacket systems.
Preferred equipment suppliers like Enerquip, LLC proactively participate in the ASME-BPE committee meetings to help shape the standards that apply to shell and tube heat exchangers. If your pharmaceutical manufacturing operations require new or upgraded shell and tube heat exchangers, or you would like to discover where you can improve your sanitary processes to meet ASME-BPE standards, reach out to the expert engineers at Enerquip.