CMMS is of particular importance in the pharmaceutical industry, as the several pieces of equipment and their maintenance are subject to much higher standards than in other sectors.
That’s why innovation and rationalization - when it comes to maintenance management - are of crucial importance for pharmaceutical companies, as they need to comply to strict production rules while minimizing costs. Choosing a powerful CMMS software is therefore important.
PARTICULARITIES OF MAINTENANCE IN THE PHARMACEUTICAL INDUSTRIES
The pharmaceutical industry is a special field, in which norms and regulations are particularly strict because of health challenges.
The burden of regulation in the pharmaceutical industry
Manufacturing processes of pharmaceutical products must comply with strict standards in order to guarantee the potency of the active ingredients and the quality and purity of the finished products. These standards make sure that the products are safe and effective for patients.
The slightest deviation from the rules during manufacture can have serious consequences for patients. This is why the controls and checks imposed on pharmaceutical plants are much more rigorous than the ones in other sectors.
Furthermore, medicines are very specific products, as it is not possible to detect manufacturing defects by sight, touch or smell. It is therefore impossible for the consumer and even for a health professional to know whether the product is compliant.
As such, the responsibility for the manufacturing process requires the implementation of good practices recognized in the sector to ensure the drugs’ safety and efficacy.
Drugs manufacturing’s good practices
In order to guarantee the quality and conformity of medicinal products, the production must comply with Good Manufacturing Practices (GMP), the main principles of which are as follows:
Keep a written record of operating procedures and instructions to provide a roadmap for GMP compliance and consistent quality production.
Scrupulously follow procedures and instructions to prevent contamination, inversion or error.
Quickly and accurately take note of ongoing tasks for procedural compliance and traceability purposes.
Demonstrate that systems are doing what they were designed to do by conducting formal validation processes.
Integrate processes, product quality and personnel safety into the design of buildings and equipment.
Carry out the maintenance of buildings and equipment in a regular and efficient manner.
Develop and clearly demonstrate competencies at each job.
Protect products from contamination by adopting regular and systematic habits of cleanliness and hygiene.
Implement quality controls to check raw materials and processes such as manufacturing, packaging, labeling, etc.
Plan and conduct regular audits to ensure GMP compliance and quality system effectiveness.
These principles are often referred to as the “5Ms”:
Machine: identified, well-maintained, cleaned, qualified, etc;
Method: available, detailed, precise, approved, audited, etc;
Man: trained and entrusted at the workstation;
Material: identified, controlled, etc;
Measurement: inspection, environment, qualified production infrastructures, etc.
The main principles of GMP explicitly mention the quality of equipment maintenance. Moreover, the monitoring and control of all processes appear to be key points of these good practices that the pharmaceutical products’ production must comply with.
CMMS ISSUES FOR THE PHARMACEUTICAL INDUSTRY
Due to the sector’s particularities, computerized maintenance management is a particularly strong issue. On the one hand because of the importance of complying with standards as well as processes monitoring, but also because innovation and the search for competitiveness are highly developed in the field.
Specific regulation in the pharmaceutical industry
The rules applicable to the maintenance of drug production equipment are notably defined in chapter 3 of the GMPs listed by the AFSSAPS (French Agency for the Safety of Health Products) about premises and equipment.
Maintenance procedures and documentation of interventions are subject to very strict rules. For example, a maintenance order must be issued before any work is carried out. It must contain a lot of information such as the name of the equipment concerned, the description of the work to be done, the name of the intervention, the signature of the user service authorizing the action, etc. At the end of the intervention, the work order must be completed by specifying any modifications made, the products used and the parts that have been changed.
Solutions such as Mobility Work allow operators and technicians to be autonomous: task creation, maintenance plans, notifications for every new activity…
Finally, it must be shown to the maintenance manager for evaluation and signature, and then to the user service manager to allow the return to service. Maintenance orders must be archived and remain accessible in case the same problem occurs again.
Why equipment maintenance procedures matter
The procedures must comply with many rules regarding cleaning conditions. In addition, tests must be carried out and documented before the equipment concerned is put back into service, and an assessment must be made by the user service, maintenance service and quality assurance in the event of any modification to the machine.
Finally, as some functions are considered critical, they must be tested at the end of the intervention to show that they have not changed. This is the case, for example, for the tightness of a freeze dryer or fluid bed dryer, or the integrity of an autoclave door seal. The maintenance department should then write procedures for testing these critical functions. These procedures should define all necessary parameters (test frequency, acceptance limits, etc.).
CMMS and its multiple challenges
CMMS issues for the pharmaceutical industry can be summarized as follows:
the search for innovation and competitiveness;
the strengthening of environmental, safety and health regulations;
the modernization and securing of industrial installations;
the need to manage the energy transition and move towards sustainable chemistry.
Therefore, choosing such software at the edge of innovation, adapted to the challenges of the sector and allowing cost control is essential.
MAIN BENEFITS OF A 4.0 CMMS SOFTWARE
It’s clear that having the best possible solution has clear advantages in this industry.
A 100% mobile application
The community-based maintenance management platform Mobility Work is accessible from a smartphone or tablet. As such, entering all the necessary information for each intervention is extremely simple for maintenance operators, as they can do so no matter where they are in the plant. Also, a user can go through the intervention history at any time from any device if he or she is logged in.
The platform Mobility Work is based on a community of users who exchange and follow their plant’s activity thanks to the newsfeed
Given the large amount of information that needs to be filled in at each stage of maintenance in the pharmaceutical industry, this specificity is very useful.
With 4.0 CMMS solutions, developing maintenance procedures required by current standards and planning the corresponding operations is made easier thanks to the power of the Big Data-oriented Mobility Work application. Based on data collected anonymously from thousands of users, predictive maintenance becomes a particularly valuable tool.
Smoother documents and data management
Thanks to the Mobility Work application it is possible to add and view documents at any time. This makes it much easier for all those involved in equipment maintenance to comply with the procedures imposed by GMPs.
More generally, the ergonomics of this application has been designed to make it accessible to all maintenance professionals, regardless of their IT skills, and without the need for specific training. It, therefore, encourages compliance with standards and procedures by all the teams involved in the maintenance of a pharmaceutical plant's equipment.