June 19, 2019 | 3 minute read
Since the origins of Sir Alexander Fleming’s discovery of penicillin in the early 1900s, there have been few manufacturing environments that have, and continue to strive for greater and more particular levels of exacting standards than the pharmaceutical industry.
Pharmaceutical and bioprocessing industries require products designed to prevent process contamination that adhere to international standards to ensure contamination-free drug substance.
In the biologic manufacturing industry, it’s critical that companies recognize these challenges and work diligently to follow industry evolutions, whether it be active pharmaceutical ingredients (APIs) to more modern methods of drug manufacturing such as bioprocessing (where the use of living cells now accounts for around 50 percent of major new drug discoveries).
New technologies now enable the cleaning- and sterilizing-in-place (CIP and SIP) of interior seal surfaces, without disassembly. All inboard sealing components protrude into the vessel, making them accessible for automatic cleaning and sterilization systems. This avoids microbial contamination or cross-contamination with previously processed products, and secures a high quality level in pharmaceutical production.
In addition, and particular to API manufacturers, process filtration requires fully welded cylindrical elements with wire mesh laminate filter material for CIP applications. Elements can be back-flushed, washed, and prepared for a new batch automatically; precise geometry and design enables complete removal of all residues during the CIP process.
Whether a drug company is manufacturing APIs and using glass-lined reactor vessels, or they make biologics utilizing stainless steel bioreactors, our Technology Testing Centers represent the industry’s most advanced development facilities. With this, we are able to provide a number of global mechanical seal solutions that meet current international standards such as:
- FDA compliance
- USP Class VI tested (one of six designations for plastics from General Chapter of the United States Pharmacopeia and National Formulary)
- ADI free (Animal Derived Ingredient)
- ASME-BPE (American Society of Mechanical Engineers: Bioprocessing Equipment)
We also test our components using element analysis tools—CSTEDY and CTRANS—that simulate seal face behavior in real-world conditions.
Process losses (time or product) due to system filtration can result in major monetary losses for pharmaceutical companies.
This can easily be combatted by implementing a dead-zone-free filter design in combination with effective back-pulse cleaning. In addition, using application-specific, wet lubricated, gas lubricated, contacting or non-contacting mechanical seals and custom filter designs, companies can extend equipment uptime that increases productivity and reduces total cost of ownership.
With biologics manufacturing growing exponentially over the last 20 years, so has the capacity of the major bioreactors where it is not unusual to find multiple vessels in the 20,000- to 30,000- liter size range at one manufacturing facility.
However, vessels of this size pose challenges to impeller agitation and sealing of the rotating shafts. Some require bottom-mounted agitation since this configuration of the shaft length does not require to extend up through the complete vessel.
These applications can utilize John Crane solutions such as our T586/8-1 cartridge arrangement. Alternatively, more traditional, top-mounted agitation would often specify the John Crane T5280 series of seals in wet, dry or dry gas configurations, with the latter being more preferred as it is non-contacting and eliminates contamination from seal face wear.
It’s also important to note that that there are many other solutions available, of which are often engineered to meet particular customer requirements on applications such as vessels (SS and glass-lined), SIP and CIP pumps, filter dryers, thin film evaporators, and particular needs ranging from electro-polished surfaces to reducing harmful levels of noise from seal faces.
Complying with Regulations
Focusing on compliance is the basis of process quality and control. Working with pharmaceutical producers and manufacturers requires a set of services and solutions that meet the industry’s safety and reliability standards—as well as local environmental regulations—so customers can increase their uptime and lower their license fees.
Through rigorous testing and continuous improvement, we’ve designed a number of industry-specific components that help optimize performance, efficiency and reliability. Many of our products even provide 100 percent containment of fugitive emissions, and we have more than 200 global rapid-response facilities available for service, support and repair.
From CIP components to batch documentation and certification of material integrity, we provide pharmaceutical processing companies with the engineered components and services they need.
Whether you are an end user drug manufacturer, an equipment manufacturer supplying to the pharmaceutical market, or an EPC (Engineering, Procurement, Construction) involved in the construction and specification of pharmaceutical facilities, we can assist you with your mission to improve reliability, increase mean time between repairs, reduce contamination and increase efficiency.