Pharmaceutical operations require stringent control of every aspect of production and packaging. Airborne moisture plays a critical role, as it has a big impact on hygiene compliance, powder characteristics, product specification, packaging and much more. If not protected against humidity, you can face negative consequences such as:
- Hygroscopic ingredients clumping together and congealing, which can lead to processing glitches and equipment blockages
- Bacterial activity, which impacts product and packaging quality, creating concerns with hygiene compliance and certification
- Difficulties with documentation and regulatory approvals
- Unscheduled production stoppages and high maintenance costs that limit your output and impact your profit margins
REDUCING INCONSISTENCIES IN PRODUCTION CONDITIONS
Uncontrolled or fluctuating levels of humidity, resulting from natural humidity variations in the atmosphere caused by weather and seasonal changes, are renowned for giving rise to significant problems in many key processes in the pharmaceutical industry.
These inconsistent environmental conditions and uncontrolled levels of humidity encourage bacterial activity and make it extremely difficult to maintain the kinds of consistent, meticulously controlled conditions essential for pharmaceutical standard hygiene. This can lead to problems with the documentation and regulatory approvals for quality and hygiene which are essential for pharmaceutical production.
Humid air also makes hygroscopic ingredients clump together and congeal, creating process glitches and equipment blockages - impacting overall production efficiency. Ultimately leading to unscheduled stoppages and high maintenance costs that can limit your output and lower your profit margins.
Moreover, undesirable humidity can cause significant damage and spoilage to both packaging and products even after they have left the production facilities.
STABLE CONDITIONS ARE ALPHA AND OMEGA IN PHARMACEUTICAL PRODUCTION
The Danish company Bifodan A/S, now part of Deerland Probiotics & Enzymes, has been a leading European provider of innovative probiotic solutions to the pharmaceutical and dietary supplement industries. Their customers operate with stringent quality management procedures, demanding that suppliers such as Bifodan ensure consistent product quality all year round, regardless of the weather conditions.
A key concern for Bifodan is the level of humidity present in areas where moisture-sensitive ingredients are mixed and products are packaged.
Dealing with production difficulties
Before contacting Cotes, Bifodan had encountered widespread production issues because of uncontrolled humidity - sometimes up to 12.6g/kg in the autumn months - which was causing humidity-sensitive powders to clump together and block important machinery and processes. As Bidofan production manager Hans Harborg puts it, "these problems were putting the commercial future of the company in jeopardy" by creating:
- Repeated unscheduled stoppages
- High maintenance costs
- Downtime that was limiting output and lowering profit margins
- Undesirable bacterial activity that was negatively affecting customer satisfaction and harming the company's reputation
High reliability, minimal maintenance
Cotes' experts installed a humidity management system based on a combination of adsorption dehumidification and cooling, making it possible for Bifodan to adjust humidity to the low level of 3.3g/kg that they required to avoid further production problems.
Air flows into the Bifodan production and packaging facilities can now be heated to provide the required specifications of 22°C temperature and 20% relative humidity, using only a minimum of energy inputs.
"Cotes adsorption dehumidification technology has made a huge difference to what we can achieve and has enabled us to turn our financial results right around." - Hans Harborg, production manager at Bifodan.
Regardless of seasonal changes or fluctuating weather conditions, Bidofan is now able to:
- Maintain full control over humidity levels in key production and packaging areas
- Ensure end-to-end consistency and manage product quality effectively
- Maximise production uptime
- Significantly reduce maintenance costs
FULL CONTROL COUNTS
With Cotes adsorption dehumidifiers, well-managed atmospheric stability in manufacturing facilities will have significant benefits for any pharmaceutical company's market position, contributing to:
- End-to-end consistency in production and packaging processes, regardless of seasonal changes, weather and other phenomena
- Lowered risk of powder clumping, blockages and spoilage, resulting in better control of key processes and lower maintenance costs
- Greater output and better profitability, thanks to fewer production glitches and less downtime
- Easier, more effective quality management, as required in the pharmaceutical industry
- Better hygiene compliance, thanks to end-to-end control of humidity conditions
Controlled humidity enables you to establish and maintain, precisely the required environmental conditions for manufacturing, packaging and storing pharmaceutical products - and their ingredients - that are hygroscopic and/or humidity-sensitive. This increases quality and reduces risk at every stage of your pharmaceutical production setup, regardless of configurations.
Cotes adsorption dehumidifiers are the easiest and most cost-effective way to remove undesirable and uncontrolled humidity from any pharmaceutical production setup. This enables you to maintain consistent, controlled specifications, regardless of the season, weather conditions and other factors that might influence the relative humidity of the atmosphere.
Cotes dry-air solutions enable you to achieve and maintain relative humidity levels as low as 20%, using only a bare minimum energy input. Learn more: Cotes adsorption dehumidifiers.
Image: Cotes Adsorption Dehumidifiers
Do you have issues with humidity?
If you would like to determine whether you need a dry-air solution in your production facilities or would like to explore what a custom dry-air strategy can do for your business, please reach out to one of our trusted partners near you.