Process Scale Chromatography

Regular preventive maintenance (PM) of your process scale chromatography equipment is the most efficient way of ensuring optimal performance and reliability. The most complete and convenient way to stay on top of your systems is to enrol in one of our service agreement programmes.

Our maintenance services include Calibration, Planned Preventative Maintenance, Repair, Corrective Maintenance, Telephone Support and Consultancy Support.

GMP systems require a calibration re-qualification at twelve-month intervals as a minimum requirement. Many customers increase this and add a calibration-only visit at six months as well as a full planned Preventative Maintenance (PM) visit at twelve months.

If there is evidence that a particular instrument is regularly outside of its specified limits, we will work with you to review the frequency of calibration and we'll advise whether it should be increased. A calibration register defining instrument range, process range, allowable error and calibration frequency should be created and maintained as a minimum FDA requirement.

Planned Preventative Maintenance (PM) helps ensure the continued optimal performance of your process scale chromatography equipment. We carry out scheduled maintenance in accordance with cGMP compliant PM protocols written specifically for your equipment. As standard, iLab engineers:

• Replace all wear parts to ensure consistent process performance.
• Verify calibration with tools which are referenced to national standards.
• Perform a system inspection to anticipate any possible risk of failure.
• Conduct comprehensive functional tests to demonstrate and document that the equipment is in full and proper working order.

We'll replace some parts as standard, regardless of condition, as part of an annual PM procedure. This will enhance the reliability of your process scale chromatography systems and reduce the risk of failure during production runs. We recommend that the following parts are routinely replaced as part of your planned process scale maintenance, and we include this as part of your annual agreement:

• Valve diaphragms
• Sanitary seals
• Other seals and ‘O’ rings
• Pump seals, check valves and diaphragms
• pH electrodes
• Batteries

Equipment, when correctly designed and installed, should operate successfully without problems. However, even the best system may be affected by unpredictable events. This could be variations in the quality of the process fluid or environmental factors and could lead to system failure - often at the most critical time.

Such events can cause costly down time or even loss of a production batch. Should you be faced with such a situation, iLab Solutions Service Engineers will assist your recovery and return your system to full operation, as quickly as possible.

As systems age, some components can be prone to failure. A Risk Assessment ensures that all aspects of potential equipment failure are fully understood and documented. We recommend a risk assessment be reviewed annually against known failure modes and updated accordingly. Our database of service records can be used to identify possible models that might fail and provide you with peace of mind - knowing that the adverse consequences of failure are minimised and that a second failure can be prevented.

Older systems will have a greater risk of failure or use obsolete components which become difficult to source as spare parts. iLab Solutions have great success sourcing obsolete parts and if not, we can recommend and provide alternatives.

All service work completed by iLab Solutions uses a defined protocol which is determined by risk assessments for both the customer's system and other known service records. If you prefer to complete your own service protocols we can provide the documentation required. These revision-controlled cGMP documents are based upon continually evolving best practices.

We'll perform a physical review adopting an FMEA approach and consider all the major functional areas of the equipment. This will identify all potential points of exposure and include maintenance frequency, personal training, spare parts strategies and operational procedures.

iLab Solutions will work with you to establish a quote based on the specificity of the equipment and your needs. For example, type of equipment, type of production, type of product, process steps, product stability, spare parts, people competencies. We will establish a process that ensures the capital investment you have made in your process scale chromatography is properly maintained for optimum system performance and longevity.

iLab Solutions are specialists in liquid chromatography separation systems, from small-scale analytical to full production capacity.

We service all makes and models of GE (Cytiva), Millipore and Pall process and analytical equipment, including:

• GE (Cytiva) Bioprocess systems
• AKTA Systems
• Millipore K-Primes
• Mettler Toledo Systems
• Sartorius