Pharmaceutical water treatment, storage, and distribution systems can be expensive. They include a variety of technologies – some of which is likely constructed of sanitary materials, and possibly complex control and automation systems. In a dynamic business environment such as the pharmaceutical manufacturing industry, used water equipment often becomes available even when it has not exceeded its useful life.
These systems or specific unit operations, once maintained in a validated state, may be repurposed for other applications or could be re-qualified (i.e. revalidated) for other applications. The capital investment savings realized by revalidating used systems can be substantial compared to the purchase and validation cost for new systems. Following are some keys to reusing, refurbishing, and revalidating decommissioned pharmaceutical water equipment.
There are no current Good Manufacturing Practices (#cGMPs) for pharmaceutical water that mandate that equipment for treatment, storage, or distribution must be new. Equipment previously in service and subsequently decommissioned may be revalidated in place, or removed and reinstalled in another location. In either scenario, the equipment needs to be revalidated – even if used on the same water source. Existing equipment documentation, including drawings, functional information, material certificates, etc., could all be leveraged as part of the revalidation process. Documents may need to be modified to account for any changes or enhancements made as part of the recommissioning process.
We have found that there are a number of sources for used pharmaceutical water treatment equipment. Companies may relocate or repurpose their own assets, which could involve upgrading or enhancing an existing system. With this process, there is an inherent comfort level – knowing where the equipment was used and how it was maintained. Additional sources include online or on-site auctions, used equipment dealers, and refurbished equipment from manufacturers. Decommissioned systems are also found on sites that have been shut down and sold to other companies. Regardless of the source, every used system presents a unique set of challenges.
Classification of Recommissioned Systems
Recommissioning of Existing Systems - This is the most common scenario for the revalidation of used equipment; a system that is unchanged and recommissioned after being removed from service. This may be due to a new product to be manufactured, the need for increased capacity, or equipment in a facility that has changed ownership. Validation of these systems is relatively straightforward if there have been no system modifications and all of the documentation associated with the system is available.
System Relocations – If a system has been relocated, even if there have been no modifications made, it would still need to be revalidated. The original Installation Qualification (IQ) and Operation Qualification (OQ) documents could be leveraged and re-executed. The Performance Qualification (PQ) would need to be completely rewritten as both the points-of-use and the feed water supply are different.
Third Party Acquisition or Unknown Origin – We have found that these are the most challenging systems to revalidate. They include systems that may have been purchased at auction or from a used equipment dealer. Often times, they include only the equipment; there isn't any accompanying paperwork. Although the intention may have been to use these systems in a pharmaceutical or high purity water application, there may be no way of definitively knowing how or for what the equipment may have been purposed. For these systems, it is critical to clean and sanitize all water contact surfaces and replace any materials in the system which may hold water so as to ensure that no foreign substances or impurities are introduced into the water produced from the recommissioned system.
Recommissioning and Validation Keys
One cannot simply reuse existing executed IQ/OQ/PQ documents. Operational data from equipment in a prequalified state may be used for informational purposes, but could not be leveraged as part of the validation process if the system was used on a new feed water source or the existing feed water source had changed. It may be possible to leverage operational data as part of a retrospective validation effort if the feed water is consistent and the system has not undergone major modifications.
A new validation (e.g. verification) sequence must be executed for any system that has not been consistently held in a validated state. Although documentation may not be available for the existing equipment, most component information can be found online. Other times, copies of manuals or drawings can be purchased from original manufacturer for custom equipment.
Process information regarding a recycled system is most important. Accurate P&IDs are essential. Less important are equipment layout drawings of the equipment as there is minimal value to recreating these for IQ purposes.
Focus on instrumentation and controls and moving parts for upgrades. Install new components that can become worn or brittle such as elastomers. This includes valve diaphragms, gaskets, seals, and o-rings.
Consider upgrades for obsolete parts where replacements may not be immediately available.
Obtain as much existing documentation as possible. Calibration certificates for instruments are irrelevant and need to be replaced no matter what. Material certs, especially for custom equipment or field piping, may not be replaceable and can be difficult to track down. Typically, data sheets for valves and instruments can easily be retrieved online or from the manufacturer.
Clean and sanitize all water contact surfaces. Sanitary stainless components such as 316L stainless steel tubing, storage tanks, distillation units, pure steam generators should all be re-passivated.
All consumables or anything that retains water should be replaced. This includes media, membranes, filters, and possibly EDI stacks.
Consider factory refurbishment and testing, rather than doing this in the field – especially for pumps and compressors.
The potential savings from revalidating used equipment (forgoing a new capital pharmaceutical water system purchase) can be extraordinary. Used equipment, possibly with the exception of 316LSS stainless tanks, may be acquired for a small percentage of the cost of a new system (pennies on the dollar). Although the risk may be higher with used equipment, this can be mitigated by using money saved on a capital outlay to purchase spare parts. Upgrades should also be considered for obsolete components, moving parts, or components have exceeded their useful life.