How to Effectively Manage the Lifecycle of Pharmaceutical Production Equipment

The lifecycle of pharmaceutical production equipment is divided into three stages: pre-operation management, in-use management, and post-operation management.

The lifecycle of pharmaceutical production equipment is divided into three stages: Early-stage management; Usage Management; Post-management.

 

1 , Early-stage management:

The acquisition of equipment requires a project initiation plan. Based on this plan, a thorough and rational review of the production process flow design should be conducted, ensuring that the User Requirements Specification (URS) is clearly defined. This includes equipment selection, cost estimation requests, procurement contracts, equipment design (Design Qualification DQ), manufacturing, and Factory Acceptance Testing (FAT). During the installation and testing process at the factory, the user unit should send personnel to the manufacturing facility to conduct operational tests on the equipment, ensuring that it has been manufactured according to the requirements specified in the user’s documentation. The user unit needs to bring the necessary materials to the factory for these test runs. If any defects are identified during operation, the manufacturer will promptly make the required modifications until the equipment fully meets the user unit’s product specifications. Only after both parties have confirmed that the equipment satisfies all requirements can it be safely returned to the user unit. Upon receiving the equipment, the user unit will perform an unpacking inspection and verification (ensuring that all accompanying documents and materials are complete). Following this, the equipment will be positioned in its designated location, with the manufacturer responsible for installation, commissioning, and operator training. Finally, once the installation, trial operation, and acceptance procedures are successfully completed, Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the equipment, and also ensure Equipment classification, establishment of equipment cards and ledgers, and collection and management of equipment drawing and technical documentation. Until Installation, debugging, and operation proceeded smoothly, culminating in delivery for use by the designated unit.

After the equipment has been running normally for a period of time, proceed with equipment acceptance based on the contract terms and the User Requirements Specification (URS), thereby completing the preliminary work on the equipment.

 

2 , Usage Management:

The equipment usage phase is a critical stage—how to maximize the equipment's effective performance, enhance its utilization rate, and ensure that, after the equipment passes acceptance checks and officially enters operation, it is managed efficiently. This includes implementing thorough inspection management, effective maintenance practices, strategic equipment upgrade and renovation planning, as well as optimizing spare parts management.

(1) Inspection Management: By conducting thorough checks, comprehensively assess the equipment's technical condition and wear status, promptly identify and eliminate potential hazards, and systematically prepare for maintenance activities.

(2) Equipment Maintenance Management: Planned maintenance, predictive maintenance, routine maintenance, emergency maintenance, and equipment-improvement maintenance.

A • Planned Maintenance: Conducting targeted repairs for equipment issues based on inspection findings that identify potential risks.

b • Predictive Maintenance: Maintenance and repairs conducted on a fixed time cycle, including the regular replacement of wear-and-tear parts;

c , Daily Maintenance:

Cleaning: Ensure the equipment is clean both inside and out, with all lubrication points—such as guideways and lead screws—free of oil and damage. Verify that there are no leaks of oil, water, or air, and that areas are free of chips, debris, and other contaminants.

Lubrication: Ensure the equipment's lubrication surfaces are properly maintained, with timely oiling, oil changes, and unobstructed oil passages.

Adjustment: Regularly adjust all operating and mating parts of the equipment to ensure proper coordination among its components and assemblies.

Sturdy: Regularly inspect the parts of equipment that require robust connections, and promptly tighten any loose fasteners to ensure safe operation.

Corrosion Prevention: The exterior and interior parts of the equipment that come into contact with various chemical media should be regularly treated for corrosion protection, thereby extending the equipment's service life.

d Emergency maintenance: Address equipment failures promptly as they occur during operation, ensuring that equipment continues to function properly.

e , Equipment-improving maintenance: During the repair process due to design-related Defects can only be addressed by making localized technical improvements to the faulty equipment, which is the key to restoring or enhancing its original technical performance.

(3) Equipment Renovation and Upgrade Management:

A Equipment renovation: Utilizing advanced technologies to modify the structure of existing equipment and enhance its performance and efficiency, bringing it up to the level of modern, cutting-edge machinery. Equipment renovation offers the advantages of requiring minimal investment, being highly targeted, and delivering rapid results.

Equipment Upgrade: Prototype equipment upgrade or technology update.

(4) Equipment Spare Parts Management:

Based on statistical analysis of frequently replaced wear parts during daily equipment operation, and with a well-planned approach to procuring spare parts for critical equipment that require regular replacement, we effectively manage tasks such as part coding, inventory tracking of incoming and outgoing parts, part information maintenance, stock management, scheduling, and cost control.

 

3. Post-management:

Post-management is divided into three parts: equipment preservation management, equipment scrapping management, and equipment disposal management.

(1) Equipment Storage Management: During the production process, if equipment is left idle for an extended period or temporarily suspended due to production reasons, it should be moved to the warehouse and the necessary procedures for equipment idleness must be completed.

(2) Equipment Scrapping Management: The comprehensive management process of handling ledgers, asset cards, and physical assets when equipment reaches the end of its service life or usage period within its functional range, or when an unexpected accident causes the equipment to completely lose its operational capability, leading to its classification as scrap.

(3) Equipment Disposal Management:

The management process for auctioning off or disposing of scrapped equipment—or equipment that has lost its usable value—is the final stage of equipment management. Through proper disposal, this process maximizes the economic benefits of the equipment, turning idle and obsolete assets into valuable financial revenue for the company.

 

                                                     Equipment Engineering Department

                                                       Ma Dianjie

                                                   2021 June 23