Weathering the Weather in Pharma Manufacturing: It’s all About Advanced Planning

Severe weather situations are increasing at a fast pace. From Hurricane Maria in Puerto Rico, to Hurricane Harvey in Texas and Hurricane Irma in Florida, storms created havoc over 2017, and those regions are still cleaning up and dealing with the after-affects.  And while it has been nowhere as devastating, here in the Northeast we’ve had our share of severe snow storms that have caused power outages across the region.

For pharmaceutical manufacturing operations everywhere, the best defense against weather conditions is a good offense. Not only can power outages erase months or years of research and development of chemicals, but it also can impact the quality and safety of critical drugs.

This article looks at steps we take to prevent down time.

From the lab to the manufacturing plant, critical instruments need to be up and running continuously.  Agitators, for example, which are on the majority of vessels, are used to mix liquids together, promote the reactions of chemical substances and increase heat transfer. When an agitator is interrupted, even for a short period of time, it can drastically alter the consistency of the chemical that is being produced.

Another key consideration is within stability chambers, which enable reliability testing by subjecting chemicals to real-world climate and wear extremes, such as temperature and humidity. Power must be continuously maintained to ensure that the specific testing factors are not compromised. Likewise, water chillers, which remove heat from one object and transfer it to another, are essential in the plant and the lab to properly maintain certain temperatures of critical processes.

These are just a few examples of the critical instruments needed to properly run a CMO lab or plant, but what they all have in common is the need for uninterrupted power.

Lessons from Puerto Rico

We’ve all learned many important lessons from the devastation that Hurricane Maria brought across Puerto Rico, and to the pharmaceutical industry there. It basically brought the industry to a standstill. Major drug companies with manufacturing plants on the island found that power wasn’t the only issue to cause a shortage of critical drugs. Plant workers were not able to get to the plant as they dealt with their own personal crises brought on by the storm, as well as blocked roads and a shortage of gasoline. Additionally, vitals materials were not able to get into closed ports and other travel venues.

While we all hope the magnitude of such a storm doesn’t impact pharmaceutical manufacturing operations anywhere again, it serves an important lesson for the need for preparedness.

Below are key precautions CMOs should consider to be as proactive as possible before a storm hits.

1. Install back-up power. The most basic and first step a CMO should take is to install even more back-up generators and Uninterrupted Power Supply (UPS) systems than you think you would even need. Both generators and UPS systems are designed to be used as a backup system when your original power source is interrupted but there is a huge difference between the two. Generators are used as a temporary power source that can keep you operational during a power outage. UPS systems provide a backup power supply that keeps your equipment running without interruptions but only for a few minutes because they’re powered by a battery. They are designed to run your system long enough for you to do a proper shut down or switch to the generator.  One thing to consider is that generators run on kerosene, which can be difficult to transport to your plant during a weather disaster, so adequate supplies should be at the ready.
2. Triage projects underway. When a storm is expected, CMOs need to determine which projects must be maintained and which can be shelved until the weather passes. In some cases, a company could lose an entire batch of a chemical if it is in the middle of processing – often at costs in the hundreds of thousands of dollars. Or, a project that has been underway in a stability chamber for two-to-three years could be wiped out in one storm. Those are the projects that must be assessed and protected, while other projects in the earliest stages can be delayed with little impact.
3. Establish a well-defined emergency plan. This type of a plan needs to be developed well before a storm occurs and it needs to be communicated and understood by all staff. It’s critical to have at a minimum, a skeleton crew at the plant 24/7, and contingencies need to be in place for adequate sleeping areas and food. A Standard Operating Procedure (SOP) should be coordinated by the Quality Control (QC) department to ensure that equipment and instruments are operational, and that staff is on-site to maintain the critical projects underway.
4. Communicate with sponsors. Finally, letting sponsors know what type of proactive emergency plans you have in place can go a long way to reassuring them that their important projects are in good hands. Likewise, immediately alerting them to project delays because of weather conditions helps them understand what to expect and to notify their own project stakeholders.

Extreme weather conditions are a fact of life that seem to grow worse each year. While much of the impact can be beyond our control, prudent and proactive planning can go a long way to keeping the lights on, the agitators moving and critical pharmaceutical projects on track.

For more info on our pharmaceutical manufacturing capabilities, call at (978) 462-5555.

About the Author

Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.