Preventive maintenance in Pharma: benefits, steps & compliance

Regular maintenance ensures equipment operates correctly, helps maintain GMP compliance, and reduces the risk of failures, ensuring your facility runs efficiently and without interruption. 

In this article, we’ll dive into the definition, benefits, and practical aspects of preventive maintenance, focusing on how it applies to the pharmaceutical industry and why it's essential for keeping operations up to GMP standards. 

What is preventive maintenance in the pharmaceutical industry? 

Preventive maintenance refers to routine maintenance activities performed on equipment to prevent malfunctions or failures before they occur. In the pharmaceutical industry, where strict GMP compliance (Good Manufacturing Practices) must be followed, preventive maintenance is crucial to ensure equipment operates consistently. 

By scheduling regular checks, calibrations, and part replacements, companies can avoid costly downtime, maintain product quality and comply with regulatory requirements. Preventive maintenance in the pharmaceutical industry helps catch issues early, ensuring equipment continues to meet safety standards as required by GMP regulations. 

What are examples of preventive maintenance in pharma? 

Preventive maintenance in the pharmaceutical industry involves various tasks depending on the equipment used. Some common examples include: 

• Calibration: regular testing and adjustments ensure that critical devices like scales and autoclaves meet precise operational standards. 

• HVAC Filter Changes: replacing filters in cleanroom HVAC systems helps maintain the required air purity for drug manufacturing. 

• Lubrication: properly oiling machinery prevents wear and tear, reducing the risk of breakdowns. 

• Seal inspections: checking seals on equipment such as bioreactors prevents contamination risks. 

• Battery checks: ensuring that emergency power systems are always ready to function. 

What are the steps in preventive maintenance? 

An effective preventive maintenance plan in the pharmaceutical industry follows a structured approach to ensure all equipment is properly maintained. Here are the key steps: 

• Inventory equipment: catalog all machinery needing maintenance, noting each item's specifications and location. 

• Schedule maintenance: Create a detailed calendar based on manufacturer guidelines and operational requirements. 

• Regular inspections: inspect equipment to catch and address potential issues early. 

• Keep records: document all maintenance tasks to comply with GMP standards and prepare for audits. 

• Optimize practices: regularly review maintenance data to improve the schedule and prevent future issues. 

What’s the difference between preventive and corrective maintenance? 

In the pharmaceutical industry, both preventive and corrective maintenance are crucial for keeping equipment reliable. However, they serve different purposes: 

• Preventive maintenance is proactive, aiming to prevent equipment failures by performing regular inspections, calibrations, and part replacements before breakdowns occur. The primary goal is to avoid unplanned downtime and ensure GMP compliance. 

• Corrective maintenance is reactive, performed after equipment failure or malfunction. It involves diagnosing the issue, repairing the fault, and restoring the equipment to full functionality. Corrective maintenance often occurs after unexpected breakdowns, potentially leading to costly delays and compliance risks. Additionally, corrective maintenance typically includes root cause analysis to prevent recurrence. Where applicable, the identified defect can be incorporated into the preventive maintenance plan to avoid similar failures in the future. 

By focusing on preventive maintenance in the pharmaceutical industry, companies can reduce the need for corrective actions, lower the risk of regulatory non-compliance, and ensure smooth, uninterrupted production. 

Maximize your December shutdown with Preventive Maintenance 

Are you planning a December shutdown? This is the ideal moment to schedule preventive maintenance and ensure your equipment is ready for 2025. 

eyetec’s certified GMP technicians can help you: 

• Perform preventive maintenance on filling lines, autoclaves, sterilizers, and washing machines. 

• Support all brands and equipment types. 

• Ensure compliance and minimize downtime.