ConsiGma: Cleaning philosophy.

ConsiGma: Cleaning philosophy.

Given that not all products require the same cleaning and containment approach, GEA has developed a cleaning philosophy for the ConsiGma® 4.0 portfolio that includes a range of options to implement the most appropriate solution for each specific application.

ConsiGma: Cleaning philosophy.

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Cleaning philosophy

CONSIGMA®

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In collaboration with the customer, we will select the right combination of cleaning options to ensure that the equipment can be cleaned to the required standard in the most efficient way.

Available cleaning principles • dry rinsing/flushing • product removal • wash-off-line (WOL) • wetting in place (WIP) • clean-in-place (CIP) • assisted clean-in-place • 1. Dry rinsing/flushing This procedure enables the production line to be rinsed/flushed with an inexpensive surrogate product that has similar feed characteristics as the API. This ensures a significant dilution of the API concentration in the line that, in certain cases, is enough to allow for risk-free disassembly and manual cleaning.

2. Product removal Product removal is an automated functionality that clears the line of any remaining product to the waste unit. We strongly advise the inclusion of this option as the cleaning operation will be much more efficient when the line is as empty as possible.

3. Wetting in place Wetting in place (WIP) covers the inside of the plant’s product contact parts with a liquid to prevent the formation of airborne particles during dismantling for offline cleaning. Using only water and no detergents, the process equipment is then subjected to a blow-out procedure and not dried. After a WIP step, the parts need to be disassembled and transported to a washing area for manual cleaning or placed in a parts washer.

4. Wash-offline Certain parts/modules of the ConsiGma® 4.0 portfolio are designed to be removed in a completely contained fashion and cleaned off-line using a dedicated cleaning kit. The best-known example of this WOL principle is the Exchangeable Compression Module (ECM) in our tablet presses. However, the same concept can also be applied to other parts of the line and/or peripherals.

5. (Assisted) clean-in-place When feasible, we also offer a clean-in- place (CIP) system to thoroughly clean and dry the equipment to make it ready for the next production run. A CIP cycle includes

different cleaning loops, including rinsing, using detergent solutions and drying, which will be configured to meet the customer’s individual requirements.

A full CIP system does not require any manual intervention from the operators. However, some elements can only be cleaned-in-place when certain parts have been removed after wetting (such as the filters in the dryer body). This is known as “assisted CIP.”

Please contact GEA to discuss which of these options is the most suitable for your specific application.

Cleaning philosophy Given that not all products require the same cleaning and containment approach, GEA has developed a cleaning philosophy for the ConsiGma® 4.0 portfolio that includes a range of options to implement the most appropriate solution for each specific application.

© GEA Process Engineering nv 2023. All rights reserved. Subject to modifications.

CIP

CIP + COP (e.g. Parts

Washer)

WIP + COP (e.g. Parts Washer)

CIP/WIP + Manual Cleaning + Cleaning Validation/Verification

Manual Cleaning + Cleaning Validation/Verification

Manual handling/cleaning effort

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