Let’s talk about everything CIP

The requirements

Controls

A procedure must detail the requirements for effective operation of CIP equipment, including:

• An up-to-date schematic diagram of the layout of the CIP system.
• Validation, and revalidation at a risk-based frequency, of the design and operation of the system.
• A risk assessment which determines the monitoring required to prevent allergenic and microbial contamination where rinse solutions are recovered and reused.
• Protection from unauthorised adjustment.
• A change management system when changes are made to the settings, methods and CIP equipment, including:
• Revalidation of the system prior to any changes.
• Pre-authorisation by a suitably competent person.

Equipment maintenance

CIP equipment must be covered by the maintenance programme.

Filters must be inspected and cleaned at a set risk-based frequency.

Flexible hoses must be stored hygienically when not in use, and inspected at a set frequency to ensure that they are in good condition.

Chemical and rinse tanks must be drained and cleaned at a defined frequency based on risk.

Maintenance can be completed by trained staff or by an external specialist contractor. Where a contractor is used the inspection reports must be retained.

Expertise

Where CIP is in place, the site must have either:

• A subject matter expert (SME) who is competent in CIP.
• Where an SME is not available, contracted expertise can be used.

Validation

Validation must be documented and approved by competent personnel to ensure that:

• The cleaning method and settings are suitable to achieve the clean required.
• That the defined process parameters will consistently meet the defined acceptable limits set.
• That there isn’t any dead spots.
• Drainage is fit for purpose to prevent pooling and splashing.
• Rinsing is sufficient to remove chemical residues.
• Maintenance requirements are set.
• Process parameters are set.

Where new CIP systems are installed, a validation must be completed by or in conjunction with the manufacturer. For current systems, where there is no installation validation, a new validation must be completed.

Revalidation must be completed, prior to a change and at a frequency based on risk.

Monitoring

The process parameters for the CIP must be monitored, to ensure that they meet the required acceptable limits.

The process parameters to be monitored are:

• Cleaning and rinse times.
• Chemical concentration.
• Temperature.
• Flow rate and pressure.

Acceptable limits must include:

• Minimum times for cleaning at the required concentration and temperature.
• Minimum rinse times.
• Rinse water testing for chemical residue and micro.

Where manual CIP is in place, the correct connections and settings must be checked.

Corrective action procedures must be in place for when the acceptable limits are not met.