Utility systems and their proper maintenance are often overlooked but they are very important to the final product quality in chemical manufacturing. The design, construction, commissioning, qualification, and routine monitoring of these systems ensure that the end product will maintain its quality when it is reproduced.
Since utilities support various equipment and processes, and play a huge role in ensuring a company meets current Good Manufacturing Practices (cGMP), they are critical to any Contract Manufacturing Organization (CMO). Their preventive maintenance ensures that they are able to accomplish their role as facilitators of safe and effective final drug delivery.
Utilities must meet both quantitative and qualitative specifications in order to be considered satisfactory. The actual criteria may vary from one utility system to another and may even be influenced by the particular equipment being supported, but the end-goal is to ensure that these systems are regularly monitored and documented to ensure that any issues in their performance are proactively addressed before they can cause harm to products or staff. This blog provides some background into how we manage our utilities systems.
At PCI Synthesis, our utilities system consists of a group of equipment and outside utilities that support all manufacturing operations. These are divided into four categories which power key areas, including:
Manufacturing Equipment Utilities
The operation of utilities is shared between the maintenance and production staff and coordinated accordingly with the production schedule. Operation of critical utilities is monitored to ensure reliable operation of process equipment during manufacturing operations.
The first group of utilities that support manufacturing equipment is comprised of electric power and compressed air. Electric power is used to operate all the facilities and process equipment, which is managed by a series of Motor Control Centers (MCCs) and distribution systems. The compressed air utility is generated by a group of air compressors which provide power to pneumatic equipment tools, instrumentation, as well as provides breathing air for Personal Protective Equipment.
Production System Utilities – Purified Water System and Nitrogen Distribution System
Purified water is a reagent used in a variety of processes for sample and media preparation, in the mobile phases of liquid chromatography and in rinsing steps. The combination of several technologies in water purification systems allow for the delivery of high-purity water adapted to each application and technique.
The purified water system purifies the potable water by means of cation exchange resin beds, softeners, reverse osmosis filters, a carbon bed, inline filters and ultraviolet treatment devices. The quality of the purified water is monitored to ensure that it is within sufficient parameters.
Additionally, Nitrogen is used to reduce the presence of oxygen in situations where combustion is a major concern. This is done through a process called blanketing. It also is frequently used to keep products dry, and even provide a safer, cleaner environment. Nitrogen Distribution also is used in the inerting of the process equipment during manufacturing and to pressure transfer batches to filters or other vessels.
Thermal Energy Utilities
The third group of thermal energy utilities consists of steam, ambient water and chilled water. These are used to provide heating or cooling to process equipment, which can be extremely sensitive to temperature.
As with other utility systems, Thermal energy utilities must be regularly maintained to ensure it is properly functioning.
The Treatment of Byproducts
It’s crucial that byproducts are effectively treated to ensure the safety of the environment and staff within a manufacturing plant. At PCI Synthesis, it is managed by a process for waste water pretreatment. These ensure that water is properly disposed of before it leaves the facility to be in compliance with industry regulations.
Key to Preventative Maintenance: A Series of Checks and Balances
Preventative maintenance is a system of procedures and tests performed on production equipment. Preventative maintenances ensures continuous reliable operation of production equipment during the manufacturing process. The system is separated into two components: Preventative Maintenance and Corrective Maintenance
Preventative maintenance procedures contain a set of instructions specifically designed for production equipment and facilities. Preventative maintenance is carefully documented using an approved checklist. Its execution is governed by a schedule and timeline for each of the applicable pieces of equipment.
Corrective maintenance is the procedure to document requests to make a correction to a piece of production equipment or to the facility at large. This is executed by the issuance and management of maintenance work orders.
In order to ensure proper preventative and corrective maintenance of utility systems, CMOs must first assess their plant capacities and production objectives, and develop a realistic utility requirements document. This document should be well-understood by all departments, the sponsoring company, as well as quality assurance (QA), since it impacts regulatory requirements.
Utility Systems power all facets of a CMO and enable the proper manufacture of critical drugs and medical devices. Ensuring not only their proper maintenance and management, but keeping pace with innovations in utilities is crucial to any successful operation.