Temperature-controlled storage solution

The development of the pharmagrade mobile cold store has been a major breakthrough in the search for pharmaceutical temperature-controlled solutions.

The need and demand for cold chain storage solutions is becoming more of a priority than ever before. This service applies to all product categories, whether it be raw materials, intermediate or finished product. The end result, in general terms, if materials have been stored correctly, is: more sales, fewer write-offs and a better functioning product with a longer shelf life.

Where the pharmaceutical sector is different from other industry applications, where public or permanent cold stores can be utilised or built, is that a lot of products are manufactured for R&D purposes, pilot plant runs. Similarly cross-contamination issues and best practices are an immediate consideration when looking at the large capital investment needed to build a permanent fixture. It is in these types of applications where the rental of portable solutions has become increasingly popular.

In the area of precision temperature controlled storage to the Irish pharmaceutical sector, CRS has been a leading solutions provider. Having worked closely with the pharmaceutical sector, the company felt that the industry had unique requirements in the area of temperature-controlled storage. The nature of the industry meant that many clients had varying critical control points and customer-specific specifications. However, the common trends in the industry were the high value of the product stored and its sensitivity to fluctuations in air temperature.

The challenge now was to further develop the unit and offer a controlled environment that would offer a minimum risk with a maximum return of product. A crucial part of the process was to ensure an understanding of the critical procedures for each production process and design a template that could be applicable to the majority of pharmaceutical applications. From the resultant survey the key concern that emerged was that of ‘contingency or redundancy’. This unit had to duplicate all critical elements of the specification and design a control system to integrate the redundancy.

The control system had to be as user friendly as possible, and that allowed the cold store to minimise the amount of intervention on behalf of the operative. Automatic controllers were employed to share the load between the refrigeration units and also act as a back-up (including automatic start) should one refrigeration unit stop running.

The next major area of concern was that of monitoring. A dual temperature recording system was needed to integrate with the dual refrigeration units and alarm systems whilst also remaining independent. Traceability of the product and temperature history during storage was required, which would also allow certain events (such as door openings

or defrost cycles) to be recorded separately. All this information needed to be made more manageable for presentations and potential audits. Software enables the information to be downloaded onto a PC, allowing one to manipulate the presentation of data, but not the information itself.

Due to the high value of the product a further monitoring system was added to give peace of mind; the user can phone the two fully independent alarm systems any time to check the temperature, or the alarm system can phone the user if temperatures should fall outside pre-set parameters. To further assist potential users, an operating manual was compiled to include all documentation required for validation, including mapping results, data sheets and so on.

CRS introduced the pharmagrade mobile cold store, designed specifically for the pharmaceutical industry. It is suitable for all product applications, including vaccines, intermediary and finished products. All systems incorporated in this product have been previously tested and supplied on medicine board-approved sites.

The pharmaceutical sector is identifying the need for additional temperature-controlled storage due to an increased, industry-wide emphasis on temperature data logging and traceability throughout the cold chain. There are several benefits to using mobile cold storage, including:

• No planning permission required
• No large capital outlay
• Full back-up and maintenance service provided
• Minimum lead times on delivery and installation

Special features of the pharmagrade unit are:

• Two refrigeration units: These share the load and also act as a back-up (including automatic start) if one refrigeration unit should stop running.
• Two fully independent computerised temperature recording systems:
• These give full traceability of temperatures and events.
• Two fully independent alarm systems, for complete peace of mind: The user can phone any time to check the temperature, or the alarm system can phone the user if temperatures fall outside pre-set parameters.
• Easy-to-open door: The door is pallet wide, with a man trap release handle to facilitate loading and unloading.
• Aluminium flooring: Hermetically sealed to prevent contamination.