In addition to its constant need for innovation, the pharmaceutical industry is subject to particularly strict regulations. The maintenance of production sites and equipment thus plays a major role: perfect industrial maintenance management is therefore not only a competitive advantage, but also a necessity to comply with standards. For pharmaceutical companies, deploying a comprehensive maintenance strategy is essential to remain competitive without compromising safety.
Specific Challenges in the Pharmaceutical Sector
The main concern of the pharmaceutical industry is regulation, with strict standards governing product manufacturing. A perfect traceability of interventions, optimal reactivity in the event of problems, and constant maintenance of facilities to ensure hygiene and safety are required. Thus, companies in the sector must be vigilant to not overlook any issues with their equipment.
Good Manufacturing Practices (GMP)
The pharmaceutical sector is characterized by a set of rules essential to product quality and safety, the Good Manufacturing Practices (GMP). These standards directly impact how industrial maintenance in the sector must be managed and documented. Generally classified into five categories (Personnel, Products, Processes, Procedures, Place), GMP particularly includes:
- Complete and detailed documentation of maintenance procedures and instructions
- Rigorous compliance with maintenance procedures and instructions to avoid any risk of contamination or error during interventions
- Real-time recording of all maintenance operations carried out
- System validation to ensure that maintenance systems fulfill their intended functions
- Facility design integrating product quality requirements, personnel safety, and process efficiency
- Proactive maintenance for buildings and equipment to ensure continuous proper functioning
- Training and skills development for each maintenance position to guarantee the appropriate expertise for all interventions
- Hygiene and cleanliness to prevent any contamination of products
- Integrated quality control for all maintenance stages, from checking spare parts to post-intervention validation
- Regular audits to assess compliance with GMP and the effectiveness of the maintenance system
Risk Management of Contamination, a Particularly Important Issue
Contamination risk management is a particularly crucial aspect of maintenance. Interventions on equipment can indeed be a potential source of product contamination, potentially affecting patient health.
To minimize these risks, several measures must be implemented:
- Cleaning and disinfecting procedures
- Environmental control
- Specific training of personnel
- Use of compatible materials
- Meticulous planning of interventions
All these measures require great rigor in industrial maintenance. Total traceability of interventions, parts used, and modifications made to equipment is necessary.
Maintenance Techniques
In this highly regulated context, total reliability and availability of equipment are only possible by adopting a comprehensive approach to maintenance, such as Total Productive Maintenance (TPM), which places maintenance at the heart of industrial performance. Various strategies exist, often combined:
- Preventive maintenance: This aims to anticipate breakdowns through planned interventions based on predefined indicators (usage time, number of cycles, etc.). This approach allows for greater reactivity and minimized risks of contamination or production stoppages.
- Predictive maintenance: Leveraging data from the Internet of Things (IoT) and artificial intelligence, predictive maintenance anticipates failures by analyzing the real-time condition of equipment. It allows for finer optimization of interventions and reduced maintenance costs.
- Corrective maintenance: Although the goal is to minimize it, this form of maintenance remains common and often necessary. In the pharmaceutical sector, corrective maintenance must be particularly reactive and follow strict protocols to limit the impact on production.
Technological Solutions to Meet the Challenges of the Sector
Advanced technological solutions are increasingly important for pharmaceutical companies looking to better manage their maintenance. Maintenance software indeed provides precious precision and visibility.
Computerized Maintenance Management System (CMMS)
A CMMS plays a central role in optimizing pharmaceutical maintenance. It allows for:
Asset and inventory management
Easy import of existing maintenance data, customization of equipment records, and precise tracking of spare parts inventory: the CMMS ensures rigorous and real-time tracking of equipment, especially the most critical, across all sites.
Intervention reports and shared documentation
In addition to simplified field entry and quick consultation of diagrams and plans, maintenance documentation becomes entirely collaborative with a CMMS. Efficiency of teams, as well as compliance with standards, are thus ensured at all levels.
Planning and analysis
The maintenance software deeply simplifies predictive and preventive maintenance. Software data is used to create maintenance plans, generate detailed reports, and develop complete dashboards. Thus, it is possible to gain a broader perspective on maintenance.
Integration and collaboration
Recent maintenance software allows connections with other systems (ERP, IoT) and features internal and multisite communication functionalities. This connectivity is essential to pool maintenance-related data and better analyze its processes.
Emerging Technological Innovations
Beyond CMMS software, other technologies contribute to transforming pharmaceutical maintenance:
- Internet of Things (IoT): Connected sensors enable real-time monitoring of equipment, feeding predictive maintenance systems
- Artificial Intelligence (AI): Analyzing equipment-related data helps predict failures and optimize interventions
- Augmented Reality: This technology simplifies complex interventions by guiding technicians step by step
- Mobile Solutions: Completely mobile CMMS applications, accessible from the field, make it easier to enter and consult maintenance information in real time.
These technologies, combined with a powerful CMMS, bring real visibility over equipment and greater ability to anticipate.
Case Study: Rivadis Testimonial
The example of Rivadis illustrates the benefits of a modern approach to maintenance. Subject to standards close to those of the pharmaceutical sector (ISO 9001, 14001, GMP hygiene), Rivadis moved to the DIMO Maint MX solution for managing its maintenance in the cloud. Thanks to CMMS, Rivadis was able to:
- Improve preventive maintenance management with more flexible handling of work orders
- Better anticipate breakdowns and industrial maintenance needs
- Bring real mobility to technicians, capable of more autonomous interventions
- Speed up inventory management with QR Codes
Thus, adopting modern maintenance software not only eased the team’s burdensome part of their mission but also helped to break down maintenance barriers. Rivadis’ data became more accessible and reliable, as did its processes.
Therefore, maintenance software allows for the adaptation of industrial maintenance to a sector as demanding as pharmaceuticals, regardless of the company’s profile. CMMS streamlines exchanges and accelerates maintenance by eliminating unnecessary procedures. This is essential for pharmaceutical players wishing to free themselves from any regulatory gray areas and remain competitive, no matter the circumstance.
