SELECTION

Manufacturing equipment should be designed, located and maintained to suit its intended purpose. Industry comprises of three Ms i.e. Men, Machine & Material. All three resources are critical for an industrial output. Machines play critical role in the quality & quantity of an industrial output. Hence equipment selection becomes a critical parameter of any industry & pharmaceutical industry is also not an exception. Due to the high quality demand for Pharmaceutical Products, the pharmaceutical machines selection becomes far more critical as compared to other process industries. One needs to pay more attention at the stage of selection, installation, commissioning & validation. There are certain regulatory bodies which govern the quality and safety standards of all industrial equipments and usually these standards are set at very high level.
Procurement Process

The process starts well before the project layouts are conceptualized. There are certain definitive advantages of preparing the procurement plan at the beginning of project conceptualization. The procurement plan shall ideally have the following elements " Product Line Up " Process Requirements " Technology " Output/Capacities " Product Output Range & Steps(Flexibility) " EHS Compliance/Energy Efficiency " Specifications " Dimensions " Energy Sources " Services/Utilities Required " Desired Level Of Automation " Commercials, Taxation, Benefits " Vendor Assessment & Qualification " Delivery Lead Times " Commissioning & Qualification Requirements " Validation Requirements " Regulatory/Statutory Compliance " Maintenance " Clean ability " Durability/Functional Ease/User Friendly

Each of the above element has got its own critical importance. e.g. for choosing right equipment, one must know the product in detail and various factors that would govern the product's quality compliance. Similarly, equipment capacity sizing is also very important and can save millions in capital investment and operational cost if chosen correctly. Typically pharmaceutical being a batch processing industry, there are wide ranges of batch sizes to be handled thus making it very tricky for the purchase department to choose the correct size of equipment which can offer a very good amount of flexibility in terms of capacity handling. The selection should be such that it's neither too large for some of the batches nor too small for some. Specifying equipment is quite important as one need to consider all the requirements in terms of quality, productivity, regulatory compliance, automation requirements etc. Environment, Safety and Hygiene (EHS) compliance is now a days a sort of mandate for all industrial equipment. One must look at this aspect quite seriously as it's very critical factor. This factor has got direct impact on three most critical business drivers Profit, Quality and Safety. A safe equipment means safer employees, higher morale & higher productivity. Employees with higher morale do deliver the top quality products and quality products means improved profits. Similarly, our responsibility towards environment in which we live & operate has got utmost importance. One must select equipments which are energy efficient & less polluting in terms of noise, air and water. Some of the critical EHS considerations in equipment selection shall have " Machine Guarding " Electrical Safety " Lock-Out / Tag-out " Control of Hazardous Energy Sources " Exhaust Ventilation " Process Safety " Air/Water Pollution Control " Containment Standards Automation levels of equipment have got direct impact on output and quality of the product. Lesser the manual intervention, better the quality of the product. This rule applies to most of the manufacturing industries, especially in pharmaceuticals where product quality is of highest importance.

Machine dimensions are important as they define the foot print of equipment which is directly related to the space and volume they occupy thus having great impact on overall operating cost. More compact equipment offer better space utilization and result in lesser operating & maintenance cost. Energy sources for the machine are directly responsible for the machine performance, operational cost, efficiency and maintenance. One must consider the machines with appropriate energy source & shall always perform lifecycle cost analysis while choosing the right source of energy for the equipment. At the same time, balancing is required between product quality, output capacity, functional requirement, operating cost and safety of the operator. None of these can be neglected. e.g. whether to go for electrical steam generator or to go for diesel fired boiler will be dictated by the functional requirements and operating cost.. Technological upgrades are happening at very fast pace now a days as compared to a decade back. As a result of this, there are always numerous options available for the purchaser. However, purchaser must keep himself updated with the technological advances. This helps purchaser to leverage the technological advantage and to get better value for money package. Maintenance Machine Guarding is one of the critical parameter and needs to be evaluated by subject matter experts. Provision of guard interlocks and Lock-Out Tag Out facility needs to be verified before the equipment is being dispatched as these functions will be useful right at the installation & commissioning stage. Adequacy of all safety devices must be tested during progress review checks. Particular requirements & special equipment needs must be addressed appropriately in design specifications. e.g. earthing protection & earthing interlocks is must have for a fluid bed dryer. A punching tool guard and interlock must be provided for blister packing machine. Empty Capsule loading station must have the guard & interlock in place. Emergency stop switches must be provided on all critical equipments and they shall be accessible from all potentially hazardous locations. Industrial Hygiene requirements are also part of the safety requirements. These requirements deal with employee exposure monitoring, performance monitoring of exhaust ventilation system & containment devices such as down flow booths, isolators and fume hoods.

Similarly, provision for stack monitoring access and effluent measurement becomes an essential requirement to ensure the environmental compliance. Ergonomic considerations help an organization to ensure that all employees are protected from the potential injuries that can be caused because of occupational practices. Last but not least, one must pay an attention to the maintenance requirements of equipment. The equipment must be easy to operate and maintain. e.g. the equipment design should be such that all mechanisms should be easily accessible. All guards shall be light weight and easy to remove & fix. Best maintenance practices always pay back in long run. It also helps to optimize the spare inventory and keep the equipment performance in highest order thus ensuring employee safety and top class product output. One must also consider the provision for clearing jams, mechanical settings, routine maintenance access as these factors have great impact on employee safety and equipment performance. Electronic Equipment Logs or conventional job card systems can help an organization to upkeep the maintenance of facility and equipment. The centralized system always helps to handle the spare parts management with ease and certainly helps in reducing revenue expenditure budgets.