The scope of this study is to explore the understanding of Pharmaceutical Equipment Management and its challenges. Pharmaceutical manufacturers have to ensure that their manufacturing equipments are properly designed, installed, tested, operated and maintained throughout their service lifetime.
During these service lifetimes manufacturing equipment will require preventive and corrective maintenance activities which may involve the replacement of parts within the systems. Equipment parts replacement must be performed under the appropriate change controls to ensure that manufacturing equipment remains in a validated state with respect to installation, operation and performance.
The main focus of Maintenance Department is to provide reliable manufacturing equipments with cost-effective and targeted maintenance. Consider the following sources of unreliability for improvement – poorly defined operating procedures, ineffective cross functional team work, lack of measures and targets, poor design for maintenance, inadequate equipment monitoring and its knowledge of condition and lack of technical skills.
Consider the following steps under Pharmaceutical Equipment Management:
1. Risk-based approach to Equipment Maintenance
- Use a risk based approach to classify every equipment in terms of its impact on product quality as:
- Product Critical Equipment – Equipment whose failure may directly affect product quality. E.g. Mixing Tanks/Vessels.
- Process Critical Equipment – Equipment whose failure may indirectly affect process performance which in turn will affect final product quality. E.g. Temperature Monitor.
- Zero Impact Equipment – Equipment whose failure will not impact final product quality.
- Environmental Impact Equipment – Equipment whose failure may directly affect environment. E.g. Boiler.
2. Update Maintenance Plan after every new equipment introduced
Updating of the Maintenance Plan should be included as an activity in the procedure covering every new equipment installation.
3. Training of Maintenance Staff/Employees and Contractors
The GMP Regulations require all contractors to be trained appropriately before entering GMP areas.
4. Consider the GMP impact of Lubricants
Lubricants are often ignored in terms of their GMP impact, they can have direct contact with the product. The assessment and impact of lubricants in use and introduction of new lubricants on product quality should be assessed and documented.
5. Document Maintenance Activities
Maintain policies, standard operating procedures for all maintenance activities. Use a risk-based approach to priorities the documentation need.
6. Use Modern Maintenance Management Techniques
The pharmaceutical plants can adopt the best-practice techniques like Total Preventive Maintenance1 (TPM), Condition Based Monitoring2 (CBM) and Lean Maintenance3 with both GMP and company’s expectations that are continuously improving process.
7. Equipment Documentation
The documents such as Manufacturer’s Operating Manual, Installation Manual, Service Manual, Engineering Drawings, Process and Instrument Diagrams and details of the validated state of the equipment are to be maintained.
8. Consider Maintenance Department during equipment purchases
The Production Engineers and Product Development Scientists should consider Maintenance Department while giving selection criteria for equipments.
9. Targeted Criticality Analysis Approach
This approach is used to increase equipment reliability, reducing consequences of failure, production cost of equipment failure, outage time and repair cost.
Total Preventive Maintenance (TPM)
It is the application of preventive maintenance strategies in an organized and standardized method. It is an approach that places the responsibility for routine maintenance on the workers who operate the machinery, rather than employing separate maintenance personnel for that function. TPM gives employees a sense of responsibility and awareness of the equipment they use.
Condition Based Monitoring (CBM)
It was introduced to maintain the correct equipment at the right time. Such a system will determine the equipment’s health, and act only when maintenance is actually necessary. Ideally it will allow the maintenance personnel to minimize spare parts cost, system downtime and time spent on equipment maintenance.
A systematic, logical method of identifying and eliminating non-value-added activities using continuous assessment and improvement to achieve improved maintenance effectiveness in response to customer demand.
The Preventive and Corrective Maintenance Plan should be planned by considering the history of particular equipment failure; this in turn will help in reducing production cost of equipment failure, outage time and repair cost. It is wise to adhere to the manufacturer’s recommendations while procuring equipment. Equipment manuals should be read through and thoroughly understood before it is installed. Irrespective of availability, it is good idea to purchase a stock of spare parts while buying the equipment and ensure that manuals and clear diagrams for identifying spare parts are supplied with the equipment. Use Modern Maintenance Techniques.
- 21 CFRs, Part 210 and 211
- FDA, Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, August 2003.
- FDA, Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations, September 2006.
- Paul Lawrence, A plain man’s guide to maintenance. Appropriate Technology, British Medical Journal.
- PQRI. Functional Equivalence for Equipment Manufacturing Technology Committee – Risk Management Working Group.
- FAT/SAT aplication
- Regarding line Clearance
- PQ of vial washing machine
- Validation of PLC based Automation
Rajkumar P. Patil
Sr. Production Officer.
Rajkumar is a PG in Industrial Chemistry and has a professional 8 years experience in manufacturing of the following streams of Therapeutic Formulations – Tablets, Oral Powders, Oral Liquids (Solution & Suspension), Paste, Talcum Powders and Shampoos.
Provimi Animal Nutrition India Pvt. Ltd.,
C-7/22, KSSIDC (IE),
Yelahanka New Town,
Bangalore – 560106. Karnataka, INDIA.
E Mail: firstname.lastname@example.org
Mobile No. +91 99456 42935.