Bioprocess chromatography system

Regular preventive maintenance (PM) of your process scale 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.

Calibration Interval

The minimum requirement for GMP systems is a calibration requalification at twelve-month intervals. Many customers increase this frequency to six-month intervals with calibration only support half-way through the year and 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 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.

Preventative Maintenance (PM)

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

  • 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.

Some parts are normally replaced regardless of condition, as part of an annual PM procedure. This enhances the reliability of a system and reduces 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 will 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

Breakdown, Repair & Corrective Maintenance

Equipment, when correctly designed and installed, should operate successfully without problems. However, even the best system may be affected by unpredictable events such as variations in the quality of the process fluid or environmental factors and may fail - 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.

Risk Assessment

As systems age, some components may 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. To support this, we have a database of service records for a large number of process scale Chromatography and Ultrafiltration systems which can be used to identify possible models that might fail. We can provide you with peace of mind, knowing that the adverse consequences of failure are minimised and that a second failure will 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. If not we can provide alternatives.

Protocols & Documentation

All service work completed by iLab Solutions uses a defined protocol determined by risk assessments for both the customers system and other known service records. For those customers who prefer to complete their own service protocols we can provide the documentation required. These revision-controlled cGMP documents are based upon continually evolving best practices.

A physical review adopting an FMEA approach will be performed to consider all the major functional areas of the equipment, identifying all potential points of exposure and including, but not limited to, 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 (type of equipment, type of production, type of product, process steps, product stability, spare parts, people competencies) to establish a guarantee that the capital investment you have made is properly maintained for optimum system performance and longevity.

Equipment Covered

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 lab scale equipment, including:

  • GE (Cytiva) Bioprocess systems
  • AKTA Systems
  • Ultrafiltration Systems
  • UV-Vis 920 Analyser
  • Millipore K-Primes
  • Mettler Toledo Systems