Data potential and how to approach hygienic design at EHEDG

Matilda Freund​ of Mondelēz told attendees at the EHEDG World Congress on Hygienic Engineering & Design that as part of HACCP there are three categories of risk: microbiological, chemical and physical.

Mondelēz’s products are marketed in 165 countries with 68 facilities in the EU and production at another 105 external manufacturers.

Direct losses include downtime, lab costs and destruction of contaminated food and indirect losses are unsatisfied consumers, decrease in demand, loss of shelf space and of quality image.

Freund said the amount of verification with suppliers is based on internal decisions and experience with them.

She added challenges include consumers demanding “fresher” foods with fewer preservatives and changes in formulation or equipment may provide an open door for spoilage organisms.

Allergen management control​

Dirk Nikoleiski​ said an allergen management program should be based on a hierarchy of controls.

This involves avoiding introduction of an allergen into the facility that does not already contain it, segregation of equipment where possible, well documented cleaning and inspection procedures to prevent allergen cross contact or crossover and if the risk is present a precautionary label statement should be used.

Nikoleiski said cleaning on a chocolate line can last up to eight hours.

“Hygienic design has evolved, we are still not there yet but it came into people’s minds and on the agenda. We don’t discuss with an equipment manufacturer without the hygienic design topic being raised.​

“We don’t rely on “industry standards” and trust compliance to legal requirements. We have a culture of hygienic design and involve relevant stakeholders early on in projects - there is no simple copy and paste of existing design solutions.”​

Jurgen Hofmann ​from hygienic design Weihenstephan said an EHEDG certificate is third party evaluation of the design of components.

Hofmann said it certifies individual pieces of equipment but the equipment can be installed in the wrong way and used incorrectly meaning it is no longer cleanable.

He added certification could take one or two years if there are problems in cleanability and 80% of equipment has problems at first.

Hofmann said ED means for dry cleaning and EL is for liquid cleaning and the month and year show it was easy to clean based on knowledge at that date and not necessarily current information.

“Benefits for the food manufacturer are selection of hygienically designed equipment, guarantee equipment is easy to clean, it fulfils EU machinery directive and simplified cleaning validation.”​

EHEDG is developing test methods for equipment used for open processing and updating old certificates.

Marc Mauermann​ of Fraunhofer presented the early work of an EHEDG project to develop a test method to assess cleanability of exposed surfaces.

Having such a method will result in a more transparent and robust EHEDG certification scheme.

He said it is to be able to compare cleanability of different pieces of equipment with a reference but is for screening purposes only and not indicative of performance in industrial situations.

Approach and potential of data​

Hein Timmerman​ of Sealed Air said cleaning and disinfection validation was not a burden but an opportunity.

He said it can help reduce the risk of product contamination and consequences like product recalls, damage to the brand and loss of market share. ​

For most food companies it fits into the quality system of BRC 7 (2015), IFS Food 7 (expected 2017) and FSSC 22000. SQF edition 8 is also expected at the start of 2017.

Timmerman said monitoring and verification are tied together and part of an integrated cleaning approach.

Monitoring is routine measurements during cleaning that serve as indicators of whether the process is in a state of control.

Validation is on new lines required by changes in a process, raw materials, formulations or product; the production process like pasteurization or sterilisation conditions; run length; new worst case scenarios; CIP installation modifications, temperature, flow rates, times, chemicals, change in SOPs or personnel, especially in manual cleaning operations).

He said there should be three positive results before accepting a cleaning validation protocol and it should be documented due to regulations.

Timmerman said in practice there is little time, it is labour intensive and involves an interruption of production. Due to lack of statistics, decisions can be made on empirical data, traditional CIP parameters (flow, temperature, conductivity) and do not provide qualitative data on food safety.

This is where a spectrophotometer, using UV, VIS or NIR spectrums comes in, he added.

This technology, from the acquisition of TTS CIPTEC​, enables a decision to be made based on statistics using real cleaning data to optimise and statistically prove cleaning validation.

John Holah ​of Holchem Laboratories said it is important to understand the process and product the machine is intended to manufacture and how equipment will operate, be installed and serviced, to ensure continued (validated) operation of any processing or cleaning.

Holah said questions include what is the equipment designed for: is it product/process specific or for a broad range and is pasteurization or aseptic involved?

It is also important to know where equipment will go, for example a basic area such as a warehouse, medium area where general processing is done or for pasteurization in a high hygiene area.

Steven Multer​ of HECHT Technologie talked through cleaning of factories handling dry foods with no liquid used starting from raw material arrival until packaging final product.

“Production equipment and conditions for dry foods are not built and suitable for wet conditions. For easier and cheaper production these environments are designed to exclude any water.”​

With a water activity (aw) <0.6 there is no microbiological growth but other parameters are involved such as bacteria having increased heat resistance, potentially surviving for long periods of time and being transferred and contaminating the product stream.

Cleaning procedures (wet or dry cleaning) depends upon moisture content of dry material.

Multer said dry cleaning must be validated when allergens are present as it is almost impossible to have an effective dry clean with low threshold allergenicity (such as peanuts) so the best solution is wet cleaning.

Manual or semi-automatic dry cleaning can involve brushes, sweeping, scraping, pigging, dry ice blasting, rinsing with a neutral product, air jets and retractable nozzles or a vacuum cleaner.

Pressurized air should be avoided as it blows dirt and soil from one end to the other, possibly creating a much bigger problem.

Rafael Soro​ of ainia Centro Technologico looked at sustainability and hygienic design.

A cleaning and disinfection operation uses electricity, water, thermal energy and cleaning agents generating wastewater and organic residues, said Soro.

Cleaning and disinfection is the main water consuming operation in most food sectors, he added.

Soro detailed the LIFE ECODHYBAT project​ which measured the environmental impact associated with cleaning and disinfection operations.

The main conclusion was hygienically designed equipment saves an average of 38% in water consumption.

Results have been submitted to the IPPC Bureau for consideration which is going to consider it for a best available technique (BAT).