By: Raj Divi, Engineer III, CQV

Properly evaluating equipment data can be a big pain point for pharmaceutical manufacturers when specifying and procuring new equipment to purchase. The process involves assessing detailed technical information provided by equipment vendors in data sheets, and various challenges may arise during the procurement process. IPS, specializing in commissioning, qualification, and validation services, can help our clients navigate these pain points of evaluating instrument data sheets for new equipment purchases. Consider the helpful guide below:

1. Intended Purpose

Procuring pharmaceutical manufacturing equipment demands an in-depth understanding of complex technical specifications in instrument data sheets. The challenge lies in comprehensively mapping out the equipment’s intended purpose, considering its implications on regulatory compliance and operational efficiency.

2. Technical Review of Instrument Performance Metrics

Interpreting performance metrics in instrument data sheets goes beyond a generic analysis. Inadequate interpretation to meet specific pharmaceutical manufacturing needs may result in selecting equipment with suboptimal performance, leading to increased wastage, lower yields, and compromised product integrity.

Accuracy: In the pharmaceutical industry, precision and accuracy are paramount. Ensure that the instrument’s accuracy meets the stringent requirements of pharmaceutical manufacturing. Check if the accuracy is specified across the full operational range and verify if it complies with any industry-specific regulations or guidelines. Minor inaccuracies can have significant consequences in pharmaceutical production.

Precision/Repeatability: Precision refers to how consistently the instrument delivers the same result when measuring the sample under the same conditions. In pharmaceutical processes, repeatability is essential, as it impacts product consistency. Evaluate the instrument’s specifications to understand its ability to provide consistent results, especially when dealing with critical measurements.

Resolution: High resolution is essential in pharmaceutical processes, especially those involving small volumes or concentrations. Resolution refers to the slightest change in the measured property that the instrument can detect. Ensure that the instrument’s resolution meets the requirements of your specific application to avoid missing critical details.

3. Review of Equipment Impact on Production Site

Evaluating the equipment’s physical dimensions and utility needs is vital to ensure that the equipment is compatible with the existing production site requirements.

Integration Capabilities: Integration capabilities refer to the instrument’s ability to connect and communicate with other systems, such as control systems, data acquisition systems, or enterprise resource planning (ERP) systems. Evaluate the instrument’s integration options and ensure they are compatible with your facility’s infrastructure. Consider any additional costs or requirements for integration, such as software licenses or interfaces.

Scalability: Scalability refers to the instrument’s ability to handle increased workloads or integrate with larger systems. In the pharmaceutical industry, production volumes and requirements can change over time, and it’s essential to have instruments that can adapt and grow with your process. Evaluate the instrument’s scalability and ensure it can meet your future needs and requirements.

4. Integration with Existing Systems and Environment

Integrating new equipment with existing systems requires a comprehensive understanding of the latest equipment and the current operational landscape. Poor integration may result in data discrepancies, communication breakdowns between systems, and compromised overall operational efficiency.

Temperature Range: The pharmaceutical industry operates under controlled environmental conditions. Ensure that the instrument can function within the specified temperature range of your manufacturing process. If the process involves extreme temperatures, such as in sterilization or freeze-drying, the instrument must be capable of withstanding these conditions without compromising accuracy or reliability.

Vibration and Shock: Pharmaceutical manufacturing facilities can be subject to mechanical vibrations and shocks, mainly if heavy equipment or machinery is operating. Assess whether the instrument is designed to withstand vibrations and shocks commonly encountered in your facility. Ensure that it can maintain its performance and accuracy under these conditions, as failures can disrupt processes and compromise product quality.

5. Hidden Costs and Requirements

Identifying hidden costs and documenting all requirements is a meticulous and detailed process. Unanticipated costs can strain financial resources, impacting the overall project budget and potentially leading to delayed project timelines.

Maintenance and Operational Costs: Evaluate the ongoing costs associated with the instrument, including maintenance, calibration, consumables, and energy consumption. Consider these costs over the instrument’s expected lifespan to assess the total cost of ownership. Ensure that the instrument is cost-effective for your pharmaceutical process and that the ongoing expenses are within your budget.

Replacement Part Costs: Check the costs of replacement parts for the instrument. In the event of malfunctions or component failures, having access to affordable spare parts can reduce repair costs and minimize downtime. Ensure that the manufacturer or supplier offers competitive pricing for spare parts and consider the lead times and availability.

6. Conclude the Evaluation

Gap Analysis: After evaluating the equipment’s specifications, features, and performance, conduct a final gap analysis to identify areas where the instrument falls short of your requirements. Compare the instrument’s capabilities with your needs and list any discrepancies or concerns.

7. Points to Keep in Mind for Functional Testing

The equipment procurement process involves navigating a complex landscape of industry standards and regulatory requirements. Ensuring alignment with these standards demands a keen eye for detail, as regulatory penalties and the need for retroactive adjustments to meet evolving compliance standards can significantly impact timelines and financial resources

Accuracy and Repeatability Tests: Conduct accuracy tests to confirm the instrument’s precision and repeatability. Use known standards or samples to measure the instrument’s accuracy at multiple points within its range. Repeat the tests under identical conditions to assess repeatability. Ensure the instrument provides consistent results with minimal variability, crucial for pharmaceutical quality control.

Response Tests: Response tests verify the instrument’s reaction time and ability to provide accurate measurements under dynamic conditions. Assess the instrument’s performance under varying conditions, such as temperature, pressure, or concentration changes. Ensure that the instrument can respond quickly and accurately to changes in the process, as delayed or incorrect measurements can impact product quality.