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Pharmaceutical Manufacturing and Packing Sourcer

Great Atmosphere


Complete climate control is key to maintaining safe pharmaceutical manufacturing and ensuring reliable atmospheric conditions when installing variant refrigeration flow systems.

The world of medicine and pharmaceuticals has developed rapidly over recent years which, of course, has required even more stringent guidelines to ensure that products remain in the best possible condition, without jeopardising their capability. For those not involved in the physical manufacturing or retailing of pharmaceuticals, the main concern may be the accuracy of ingredients which dictates the quality and efficiency of the item. However, with such products often containing proteinaceous materials, it is crucial to understand how to maintain the right environment – including advised temperature, humidity and the lighting of the facilities.

Monitored by the Medicines and Healthcare Products Regulatory Agency (MHRA), it is essential that the entire cold chain, from the manufacturing, the packaging, right through to the end-user, is as controlled as possible. While many products will vary in their exact storage requirements, it is essential that manufacturers, distributors, transporters and retailers meet these needs while the product is within their care. This will prevent the product from becoming unstable and will allow it to be as effective as intended.

Products are classified under different categories. Low-risk items should be stored within advised conditions in order to maximise shelf life. For high-risk items, such as vaccines, insulin, blood products and other live materials, it is absolutely vital to ensure that the temperature and storage conditions are met – which also means keeping a consistent level.

It is also important to ensure highrisk products do not freeze or exceed certain temperatures. Such changes can cause irreversible damage to the product’s integrity. Records of these environments must be kept, so that data can be audited, ensuring that items remain in an acceptable and safe condition. Furthermore, pharmaceutical facilities may at times need to reveal this information for auditing and other purposes.

Climate Control

As MHRA specifications set out, manufacturers’ recommended storage conditions must be observed, which will often involve the use of specialist storage and equipment. It is also essential that monitoring systems, with sensors, are installed and, if possible, make use of an easy-to-use control system that facilities managers and other staff in pharmaceutical manufacturing and packaging plants can carefully access and adjust accordingly.

With heating, ventilation and air movement being an essential part of the method to maintain conditions, it is crucial that products used be suitable for the job in hand and are the most efficient possible in order to meet statutory guidelines. Manufacturers of heating, ventilating and air conditioning (HVAC) products will often be approached by companies looking for the best solution that will meet all their building requirements, without exceeding guidelines set in place by the EU.

It is essential that those in the pharmaceutical industry use reputable contractors and specifiers, who will design a system to meet the specific requirements of the end-user. It is also important for end-users to understand how best to achieve the advised temperature conditions via the use of the equipment to provide optimal results.

In order to regulate specific humidity and temperature levels, a complex heating and ventilating system is needed. With variant refrigeration flow (VRF) air conditioning to lower the temperature, the absolute humidity of the interior space will be reduced – thus cooling the environment. To achieve this, air conditioning systems use refrigerants that allow for easy conversion of gas to liquid, and vice versa. It is in this process that heat from inside the facilities can be adjusted and pushed to the exterior. To create the lower internal temperature, the refrigerant fluid is squeezed, which compresses the liquid molecules, creating energy and increasing the temperature. This will turn the fluid into a gas. Once the pressure of the liquid has dropped, it cools and will extract the heat from the supplied air.

HVAC Developments

As with new developments taking place within the pharmaceutical industry, air conditioning technologies are quickly changing to more advanced and capable systems. There are pressures on companies to help reduce their carbon footprint and this has dictated change in the heating, ventilation and air conditioning industry.

Some refrigerants, such as R22, can cause detrimental effects on the ozone layer, significantly contributing to global warming and an increase in UV rays. As part of the Kyoto agreement, the use of these gases should be phased out in time.

With the UK and the EU signatories to the agreement, it is crucial that heating, ventilation and air conditioning equipment across the board, including applications for pharmaceutical usage, are adequately up-to-date. Allowances will be made for system upgrades, ensuring targets are met.

Once heating, ventilation and air conditioning manufacturers have an understanding of the costly effects such legislation can bring, there are many suitable systems that can make use of pre-installed pipework and allow for a simpler installation of the interior and exterior units. This allows for reduced down-time, minimising profit loss and product wastage.

Sensors and Aids

With such strict regulations to aid heating, ventilation and air conditioning control, the installation of sensors within the site detecting temperature, humidity and pressure will allow for even more precise conditions. Where high-risk and high-quantity product is stored, it is essential that the temperature and conditions be maintained throughout the entire volume of stock, with minimal intervention and disturbance.

Here, it is essential to be in control to within an accuracy level of 0.5°C, which should be readable from outside of the unit as well as the interior. In these situations, sensor systems can be particularly beneficial as they can alert users when the temperature drops or rises too close to the upper or lower limits. Thermometers and sensors should also be regularly calibrated to ensure accuracy.

Conclusion

The nature of high-risk products is requiring ever more sophisticated storage techniques. With new types of product constantly coming into the market, including expensive therapies for difficult-to-treat conditions such as cancer, product loss through ineffective storage is becoming a serious threat. The right storage solutions will certainly provide a boost to suppliers, and will ensure that treatments safely reach the patient without falling at the final hurdle.

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Marc Diaz is UK & Ireland Country Manager at Panasonic (PHAAE). Marc is responsible for the Panasonic (PHAAE) territories of the UK, the Netherlands, Belgium, Luxemburg, Poland, and Turkey. With extensive experience at Panasonic, Marc has worked in the air conditioning division for the past nine years, having joined the company as a consultant sales engineer in Spain. He then moved to the Wiesbaden Headquarters in 2009 and last year moved to the UK base in Bracknell.
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