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A Prescription for Success

Nick Marr
A Prescription for Success - ISPE Pharmaceutical Engineering

How CMOs keep conditions controlled and reduce costs with temporary power, climate control, 100% oil-free air

Outsourcing, one of the most effective strategies with the highest benefit-to-cost ratio, gives pharmaceutical companies the freedom to prioritize internal capacities and enhance process efficiencies to remain competitive.

Mordor Intelligence predicts the contract manufacturing sector will reach $84 billion in 2021, and while demand for contract manufacturing remains healthy in the pharmaceutical industry, contract manufacturing organizations (CMOs) face increased pressure to reduce costs and run operations more efficiently.

As a result, more and more CMOs turn to temporary power, temperature control, 100% oil-free air (OFA), and moisture control systems to reduce operational costs and meet strict temperature and humidity levels maintenance, expansion projects, periods of increased production or seasonal bottlenecks where permanently installed utilities cannot keep up.

Control temperature and manage humidity levels

Adequate humidity and climate control are not only about worker comfort; they are also critical to product and process integrity. Because medical products require a specific humidity level to prevent the build-up of static charges, which could cause drugs to become sticky and introduce packaging headaches, it can become a delicate balance to strike. Facilities with installed temporary systems look for systems with 24/7 remote monitoring for both the operating equipment and the space or process being conditioned. This allows the pharmaceutical plant to monitor both their internal system process and external to ensure all quality measures are met.

Recently, GlaxoSmithKline replaced its permanent cooling system at its vaccine production site and relied on temporary cooling to preserve operations and the integrity of the site. Due to the production site’s highly sensitive temperature control, noise level, and moisture environment, the company placed an expert onsite to control the system, as well as used 24/7 remote monitoring with an active alert system to notify the engineers if vaccine cultures or the noise level strayed outside strict parameters.

Additionally, the use and maintenance of OFA systems provide a vital support component for pharmaceutical manufacturing processes to maintain a safe, clean working environment and smooth-running, reliable operations. These include diesel or electric-driven, low or high-pressure OFA compressors, as well as solutions to enhance an air stream as it relates to dewpoint and temperature.

Save money

Temperature and dehumidification control systems help the industry comply with production guidelines while reducing capital expenditures. This is because a facility only uses the equipment as needed and avoids staffing, maintenance and service contract-related expenses for owned, but rarely closely-managed, equipment. It has proven more cost-effective to rent than invest in fixed assets, particularly with HVAC and other systems needed for temperature and humidity control. This is mainly due to the engineers’ ability to design scalable temporary systems to reduce the risk of unnecessary plant equipment upon the expiration of a CMO’s contract with a pharmaceutical company.

In fact, one Virginia CMO facility used a temporary, ultralow temperature process chiller (more than 1,200 tons of installed temporary cooling), instead of purchasing a new permanent unit for its distillation column batch process as part of its one-year contract with a pharmaceutical company. The rental chiller provided the facility with better cash flow to support operations and better control of utility systems as the production schedules evolved. Installation and start-up of the temporary ultra-low process chiller system occurred within days, not months or years, with no capital expenditure.

Meet industry standards

The industry’s adherence to current good manufacturing practices (cGMP) establishes a predicate that, just like permanent units, temporary or emergency HVAC systems including chillers, air handlers, supply and exhaust fans, humidifiers, dehumidifiers, heat exchangers, pumps, cooling towers, and other critical utility systems must operate under cGMP. Energy efficiency measures incorporated into HVAC systems must also conform to current cGMP.

A fluctuation of just one or two degrees throughout a 24/7 batch or continuous process quickly leads to a non-compliant product, which is why the reliability of temperature control equipment is crucial.

When considering how best to apply temporary solutions at your site, work closely with experienced professionals to thoroughly explain the operation, assess equipment needs, and suggest the best way to keep the process running safely and cost-effectively during essential maintenance while operating under cGMP.