1. Introduction
Nowadays it is unquestionable that maintenance in any industrial sector is essential for the short and long term performance of our facilities and investments.
In the pharmaceutical sector, any incident can affect the environmental conditions of the process (which must be continuously monitored) and can even invalidate the production.
In this article we are going to contribute our experience as a cleanroom installation company, and of start-up, maintenance and qualification services on the importance of integrating the maintenance department in the different phases of the construction of a cleanroom installation, from the design to its entire useful life.
2. Fase diseño de detalle de nuevas instalaciones
In this detailed design phase we propose to involve the maintenance department in at least the following tasks.
- The maintenance department must have and deliver from the beginning its URS (User Requirement Specifications) on all types of installations, specifying materials, standardization of spare parts, brands and finishes to the installer who is executing this phase. This measure avoids cost overruns.
- Validate the design of the elements to ensure that the cost of their subsequent maintenance (in time, intervals, spare parts), will remain within the budget allocated to them.
- Collaborate in the review of the detailed, executive project, supervising accesses, sectorizations, inspection records, necessary to facilitate subsequent maintenance tasks.
3. Completion of new construction or modifications to existing facilities
It is interesting that the maintenance department can supervise and validate the works carried out by the different subcontractors, especially at the beginning and end of the works. Specifically:
- Ensure that the “As Built” documentation (drawings, diagrams, technical data sheets, commissioning and qualification dossier) is exhaustive.
- We must also ensure that the maintenance plan and procedures are delivered and incorporated into the CMMS system itself. The maintenance department must verify that it has the necessary tools and protection systems to be able to carry out its future interventions quickly and safely.
- When the subcontractors are finishing their installations, the different finishes, the identification of circuits, wiring and regulation elements will be supervised.
- At the end of the new work or modifications to the existing installation, personnel training will begin. This training must be adequate in content and adapted to the professional profile of the personnel to be trained. It should cover all installations.
By involving the maintenance department in all phases of design and execution of the works, we facilitate the handover of the facilities under the responsibility of the maintenance department.
Today, the possibilities provided by Industry 4.0 are enormous. Having all the information about the systems in a practical and secure way from codes facilitates the maintenance work. It is necessary to find the balance between the work required to have and keep this database updated and its application in daily practice.
4. Phase prior to the planned intervention
In order to be successful in the future intervention, the following preliminary work must be taken into account:
- The analysis of all the interventions carried out “correctively”, to determine why the equipment has deviated from its initial “optimal” setting.
- The study, by multidisciplinary teams, of possible improvements of the installation and optimizations (energy consumption, process yields, quality, …).
- Periodic inspections will be carried out by technical experts (also SAT of the equipment manufacturers) in which all the elements of each installation, different parameters (consumptions, pressures, flow rates, humidity) will be checked. The indicators of the filters, pumps, gates, control system and the general condition of the installations will be checked. Predictive tools such as thermographic analysis, vibrations, fluid analysis, … are inexpensive and can be of great help in detecting anomalous situations.
- Intrusive” inspections are foreseen to be carried out while the systems are stopped during planned interventions.
The result of the work we have detailed above will be attached to the preventive plan, will be added to the specific actions to be carried out for modifications in other departments, and will be passed on to planning. Planning is a very complex activity, involving time and material and personal resources. Tools such as the plant maintenance modules of ERP become indispensable in order to ensure:
- Availability of spare parts and consumables. An organized, timely purchase can represent savings. Availability of extraordinary maintenance equipment.
- Availability of personnel (in-house and outsourced), with adequate and verified skills. Safety documentation, plant-specific training.
- Availability, transmission and verification of the maintenance plan and protocol to be carried out to the professionals in charge of carrying them out
- To fit all the actions in time, including the final phases of:
- Commissioning, which consists of testing, regulation, adjustment and adequacy of all parameters and elements belonging to each of the facilities, in order to achieve the required conditions in each area.
- Cleaning, sanitization and disinfection.
- Qualification and validation. It is very interesting that the same team that performs the maintenance can perform the qualification in order to optimize the interventions and in the case that they were given, not to lengthen in the time the resolution of nonconformities.
5. Intervention
In this phase, when the installation is stopped is when we carry out the maintenance that we have foreseen/planned.
The objective is to have the work completed on schedule. It is important that someone with authority in the department follows and coordinates the progress of the work and can make decisions to increase resources or modify the planned maintenance schedule.
6. Post-Intervention
In this phase, an analysis should be made of the interventions carried out, in order to:
- Propose improvements in maintenance protocols or facilities that facilitate future interventions. Also reflect them in the company’s standards and URS.
- If work has been left to be carried out during the first days with the facilities in place, identify them and ensure their correct completion.
- Re-plan future necessary interventions either because they have not had time to be carried out according to plan or because they have become evident thanks to the intrusive inspections carried out.
- This is the moment to analyze the result of the intervention, in terms of costs, material and human resources. This will justify decisions regarding future investments and improvements.
7. Conclusions
The enormous investments made by the pharmaceutical sector in RD (in product and process), without good maintenance of the facilities, may not be amortized in the foreseen period. It is necessary to invest in the current tools available and to dedicate human resources in order to be able to work in the way proposed in this article. Those responsible for the cleanroom maintenance department in the pharmaceutical sector, must have the necessary skills in order to make these resources profitable and be able to demonstrate it with objective data.
Eudald Bogatell
Project Engineer at VALTRIA
Lidia Campillo and Gonzalo Aguilar
Collaborators
