Nearly 50% of all biotech and pharmaceutical processes are specifying single use technologies as opposed to the more traditional stainless steel hard piped system. Single use technologies offer flexible manufacturing and lower initial capital costs than a fixed hard piped system. The low risk of contamination of a single use/disposable system typically outweighs the upfront capital cost of building and maintaining the utility infrastructure to conduct validated clean-in-place (CIP) and steam-in-place (SIP) protocols.
While single use technologies reduce the cost of building and maintaining a validated GMP facility, they do have significant disposal costs including an impact to the environment. To date, this has not slowed the trend of using single use/disposable technologies.
There are several other challenges to managing a single use facility that are often overlooked in a facility’s design phase. To better understand why this poses a challenge, we must first understand the basic make-up of our single use inventory. This can be difficult, as many flexible manufacturing processes are developed after the building has been designed. Typical hard piped facilities plan for a limited amount of square footage for both product contact and non-product contact warehouse space. This complicates the shift to single use technologies for existing facilities.
Most facilities separate the non-product contact inventory from the product contact inventory due to stringent quality control requirements and the handling of product contact parts. Nearly all single use components are product contact parts; these are materials of construction tested, validated, and certified to be safe for the drug manufacturing process and ultimately the patient. Single use components require some form of clean aseptic packaging. Most commercial processes require sterilization by gamma irradiation, autoclave, or ETO. The chain of custody for handling these products is strictly controlled by quality assurance programs under FDA and BPE guidelines.
In addition, the physical properties of single use components are very different from hard piped components. Single use tube assemblies are flexible and incorporate potentially sensitive instruments that are typically individually double and triple bagged. Single use bags are manufactured with integral magnetic mixing impellers that cannot be damaged. These tube sets and bags come in all sorts of sizes that are usually not consistent. Integral single use assembly components such as filters and instruments can be positioned in a bag differently each time, making stacking difficult.
In summary, single use inventories consist of thousands of nonstructural, inconsistently and oddly shaped, and highly expensive critical spare components. These SU components need to be removed from standard packaging materials such as cardboard and Styrofoam and transferred to designated GMP inventory spaces.
Moving Single Use Inventories Closer to the Manufacturing Suites
Acuity Process Teams have supported several major end users in improving their processes by optimizing their product contact inventory footprint by moving it closer to the manufacturing suite.
The first step is to prioritize critical product contact inventories to determine what components need to be close to the process to increase productivity during batch turnover. The ability to break down and set up a new batch process quickly can have an immediate return on investment.
Innovative GMP Storage Design Solutions
Once critical inventories have been prioritized, an audit of the quantities, dimensions, and handling needs is performed. In addition, understanding how the product will flow through the facility and the ergonomic challenges that employees have when handling individual components will influence the specification of an optimal storage solution.
Transferring products from receiving to GMP storage or manufacturing areas is a balancing act. Avoiding stop gaps by having the right inventory in the right place at the right time is critical. The design of your transfer carts is an opportunity to enhance your process, improve ergonomics, and protect your product. Determining whether your carts will be in washdown areas may influence an enclosed design to protect the inventory from any overspray of chemicals. If carts are enclosed, clear acrylic doors can afford visual inventories. First in, first out flow of carts can also improve efficiency and address shelf life concerns.
Standard vs. Custom Solutions
The Acuity Process Solutions team will help you consider standard pre-engineered fixed and mobile cabinets vs. custom solutions. Often a combination of standard designs such as Metro Max shelving, Starsys mobile workstations, and high-density track systems offer cost-effective solutions. Custom designs can be tailored to unique dimensions, optimizing available space. Overall dimensions can be tailored to meet available wall and corridor areas that are currently underutilized.
GMP Materials of Construction
All materials of construction will meet or exceed GMP washdown requirements. Casters will be non-marking and sized to move heavy loads easily.
Return on Investment
Choosing the right partner to provide a comprehensive solution for transfer carts and storage equipment to enhance your workflow from non-GMP to GMP areas can deliver many benefits. Acuity Process combines years of GMP experience with innovative designs to deliver highly efficient solutions with a short return on investment. Our goal is to improve the process and improve our customers’ safety.