GEA SAFEXPERT®

We know that the appearance, flavor, texture and shelf life of your products represent the brand qualities your customers expect and demand.  For you, achieving this standard while maintaining the highest levels of hygiene and minimizing downtime is a constant challenge.  That’s where SAFEXPERT® will help, by applying our process know-how to diagnose the root cause of any existing processing problems, eliminating them and preventing any contamination in the future.

GEA SAFEXPERT® is an end-to-end process diagnostic and consultant service program to guarantee your product safety, optimize your processes and secure your product quality against any contamination. With GEA as your partner, you can stay ahead of your competition, achieve a fast return on investment, and retain customer satisfaction and brand loyalty through high quality and extended shelf life.

SAFEXPERT® is a lifetime service program from GEA that looks after your plant today and in the future, making sure that you hit your KPIs for product quality and safety, plant performance and hygiene, in everything you do.  By combining plant diagnostics with hygiene treatment and ongoing preventative actions we will be the guardians of your product quality and safety.

In the pharmaceutical research and manufacturing industry, ensuring the safety and quality of liquid dosage forms is paramount.

GEA SAFEXPERT® provides the service you need to maintain the highest standards of hygiene, microbial control and process efficiency. Derisk your procedures and optimize your plant and equipment performance with this environmentally friendly and GMP-compliant offering. From the prevention of biofilms to the identification of bacteriological species in your machinery, SAFEXPERT® helps you to protect the health of your facility, your products … and your patients.

• Plant health 360° check
• Food safety validation service
• CIP and SIP effectiveness validation and optimization service
• Microbial environmental monitoring and validation service
• Equipment contamination diagnostic service
• Process and CIP benchmark service and process KPI check 
• Preventive audit service for food safety and product quality control

GEA Solution:

1. Performance audit: Identify the major contamination areas and diagnose the root cause of contamination with ‘mapping life flora’ and ‘process mapping’.
2. Hygiene service: Restore plant initial hygiene conditions with cocktail treatment methods on the CIP system and open surface area. GEA recommend adjustment on current CIP and COP protocols.
3. Performance service: Establish adapted detection KPIs with QA team  to eliminate contamination risk before exceeding QC standard. Monthly preventive microbial and biofilm treatment.

Customer Gain:

• A deeper understanding of the production process, the weak spots: where and why.
• A drastic reduction in the incidence of non-compliant products.
• 100% contamination-controlled equipment with specific preventive maintenance actions
• Restore 11% of total production, equal to 6.8M EUR/year.
• Significant reduction in use of hot water and detergents.

GEA Solution:

1. Performance audit: Review customer QC process and perform ‘process mapping’ together with the production team to diagnose the root cause of end-product quality change.
2. Hygiene service: Modify current batch culture condition, storage time and adjust CIP protocol. Optimize QC sampling and measurement methods of incoming raw milk.
3. Performance service: Establish a specific weekly QC system for the fermentation process.

Customer Gain:

• Great learning of the production process, the critical steps of production: why and how.
• Superior raw material quality, more than 99% passed the stress test.
• A consumer satisfied end-product with good appearance, texture and flavor.

GEA Solution:

1. Performance audit: Identify water wastage and bottleneck areas on process lines.
2. Process service: Adjust and improve the cleaning system and re-design the CIP system to improve mechanical action during cleaning. Introduce RO (Reverse Osmosis) to recover water from whey.
3. Performance service: Implement additional sensors to manage the control system. Implement Water Pinch methods on control areas and a new process to recover wastewater.

Customer Gain:

• Reduced water consumption by 6% which represents 95KEUR/year.
• Established an alternative water supply system generated from whey that can provide nearly 35% of the plant’s required production water.

GEA Solution:

1. Performance audit:Troubleshoot the source of contamination by analyzing raw material quality, processing water quality, and performing a hygiene inspection on processing equipment and valves.
2. Process service:Modify existing CIP programme for both filtration system and process line and replace all valve gaskets.
3. Performance service: Benchmark system hygienic performance KPIs and establish a periodic preventive maintenance plan with GEA service.

Customer Gain:

• Saved 2M EUR on product loss, prevented further product recall. Rescued the company brand credibility and retained its consumer loyalty.
• Updated QC KPIs for better product monitoring, significantly limited the risk of contamination and fully controlled process hygiene.

GEA Solution:

1. Performance audit:Diagnose the root cause of the contamination, microbial distribution scan and metagenetic analysis were performed to identify contaminated surface area.
2. Hygiene service:5-day microbial treatment with GEA recommend cleaning program and bioactive detergent. Aging tests done before and after treatment to confirm shelf life extension.
3. Performance service:Quarterly microbial treatment and performance audit at production area and storage room.

Customer Gain:

• A deeper undersetting of the operation process, the sources of contamination: what and how.
• Clear microbiological trend showing full control of plant contamination
• Extend shelf life after treatment, from 7 days to 9 days.

GEA Solution:

1. Performance Audit:Diagnose source of contamination with a surface inspection and metagenetic test to identify the organism.
2. Hygiene service:Treat the plant with a GEA-recommended sanitizer and bioactive detergents according to SOP-defined cleaning protocols. Perform swab test and analyze both wash and rinse water using GMP- and ATMP- approved methodologies.
3. Performance service:Results suggested that redesigning the process water system and optimizing the manual cleaning process would solve the problem.

Customer Gain:

• A clear understanding of the root cause, source and location of the contamination.
• A safe and robust process that operates in a controlled microbiological environment.
• Best practice guidelines to maintain optimum plant performance and control.
• Eliminate downtime production/OPEX losses of €230k/day.