Today, there is no question that maintenance is essential in any industrial sector to ensure the short- and long-term performance of facilities and investments.
In the pharmaceutical sector, any incident can affect the environmental conditions of the process — which must be continuously monitored — and may ultimately result in production being invalidated.
In this article, we draw on our experience as a cleanroom installation company providing commissioning, maintenance and qualification services to explain the importance of involving the maintenance department throughout the different stages of a facility’s lifecycle, from initial design through to its entire operational life.
Design of New Facilities
During the detailed design phase, we recommend involving the maintenance department in at least the following activities:
- The maintenance department should define and provide its URS (User Requirement Specifications) from the outset for all types of installations, specifying requirements relating to materials, spare parts standardisation, preferred brands and finishes to the contractor responsible for this phase. This helps prevent unnecessary additional costs.
- Validate the design of equipment and system components to ensure that future maintenance costs — including time, maintenance intervals and spare parts — remain within the allocated budget.
- Participate in the review of the detailed and execution design, supervising access points, system segregation and inspection access provisions required to facilitate future maintenance activities.
Modifications to Existing Facilities
The maintenance department should be involved in supervising and validating work carried out by the different subcontractors, particularly at the beginning and completion of their activities. Specifically:
- Ensure that the As-Built documentation — drawings, diagrams, technical data sheets, commissioning dossiers and qualification documentation — is comprehensive.
- Ensure that the maintenance plan and procedures are delivered and incorporated into the company’s own CMMS (Computerised Maintenance Management System). The maintenance department should also verify that it has the necessary tools and protective systems to carry out future interventions quickly and safely.
- As subcontractors complete their installations, the different finishes, circuit identification, wiring and control components should be inspected.
- Once new construction work or modifications to an existing facility have been completed, personnel training should begin. The content must be appropriate and tailored to the professional profile of the personnel being trained, and should cover all relevant installations.
By involving the maintenance department throughout every stage of design and construction, the subsequent handover of the facilities to the maintenance team is considerably smoother.
The possibilities offered by Industry 4.0 are now extensive. Providing practical and secure access to system information through identification codes can greatly facilitate maintenance activities. However, the right balance must be found between the effort required to create and keep this database up to date and its practical value in day-to-day operations.
Preparation for Planned Maintenance
To ensure the success of future maintenance activities, the following preparatory work should be considered:
- Analyse all corrective interventions previously carried out to determine why equipment has deviated from its initial optimal settings.
- Use multidisciplinary teams to assess potential facility improvements and optimisation opportunities, including energy consumption, process performance and quality.
- Carry out periodic inspections by specialist technicians — including equipment manufacturers’ technical service teams where appropriate — covering all components of each installation and monitoring parameters such as energy consumption, pressures, flow rates and humidity. Filter indicators, pumps, dampers, control systems and the overall condition of the installations should also be checked. Predictive tools such as thermographic inspections, vibration monitoring and fluid analysis are relatively inexpensive and can be highly effective in detecting abnormal conditions.
- Plan “intrusive” inspections to be carried out while systems are shut down during scheduled maintenance activities.
The results of the activities described above should be incorporated into the preventive maintenance plan, together with any specific modifications requested by other departments, before moving into the planning stage. Planning is a highly complex activity involving time, materials and human resources. Tools such as plant maintenance modules within ERP systems are essential to ensure:
- Availability of spare parts and consumables. Well-planned purchasing can generate significant savings, while any special handling or lifting equipment required must also be available.
- Availability of appropriately qualified and verified personnel, both internal and subcontracted, together with the necessary safety documentation and plant-specific training.
- Availability, communication and verification of the maintenance plan and procedures for the professionals responsible for carrying out the work.
- Coordination of all activities within the available timeframe, including the final stages of:
- Commissioning, consisting of testing, regulating, adjusting and configuring all parameters and components associated with each installation to achieve the required conditions in each area.
- Cleaning, sanitisation and disinfection.
- Qualification and validation. Wherever possible, it is highly beneficial for the same team carrying out the maintenance activities to also perform the qualification. This helps optimise interventions and, if non-conformities arise, avoids unnecessary delays in resolving them.
Maintenance Intervention
During this phase, while the facility is shut down, the planned and scheduled maintenance activities are carried out.
The objective is to complete all work within the allocated timeframe. It is important that an authorised member of the department monitors and coordinates progress and is able to make decisions regarding additional resources or modifications to the planned maintenance programme where necessary.
Post-Intervention
During this phase, once the planned maintenance intervention has been completed:
- Propose improvements to maintenance procedures or installations that could facilitate future interventions. These improvements should also be incorporated into the company’s standards and URS.
- If any work has been scheduled for completion during the first few days after the facility resumes operation, it should be clearly identified and its successful completion verified.
- Reschedule any future interventions that may be required, either because there was insufficient time to complete them according to plan or because additional needs were identified during intrusive inspections.
- Analyse the results of the intervention in terms of costs and material and human resources. This information can then be used to support decisions regarding future investments and improvements.
Conclusions
The pharmaceutical sector makes substantial investments in R&D, both in products and processes. Without effective facility maintenance, however, these investments may fail to achieve the expected return within the planned timeframe. At Valtria, we understand the importance of investing in the right tools and allocating the necessary human resources to ensure optimal cleanroom maintenance in the pharmaceutical sector. Maintenance managers must have the capabilities required to use resources efficiently and demonstrate their performance through objective data.
At Valtria, we are proud of our role as specialists in the design, installation and maintenance of cleanrooms for the pharmaceutical sector. Our experience and commitment enable us to provide advanced solutions.
Authors: Eudald Bogatell, Lidia Campillo and Gonzalo Aguilar.