Loading...

Good Manufacturing Practice

At BEHN + BATES, Good Manufacturing Practice (GMP) means that all filling and packaging solutions are consistently designed to support validated and hygienic production processes in the food, infant nutrition, and pharmaceutical industries.

In our machine design, we meet GMP requirements and apply recognized hygienic design principles, including smooth and easy-to-clean surfaces, certified product-contact materials, and the minimization of dust accumulation and product residues.

As a result, BEHN + BATES systems can be seamlessly integrated into GMP-compliant production lines, for example in cleanroom applications, ensuring the safe and contamination-free filling of powdered bulk materials.

The objective of GMP is to ensure the quality, safety, and efficacy of products through measures such as traceability and reproducibility, as well as through the prevention of contamination.
Uwe Breulmann, Head of Hygienic Design

G(ood) M(anufacturing) P(ractice)

Fundamental principles and structures

  • Quality management system
  • Hygenic Design department
  • Documentation
  • Training and qualification of employees
  • Qualification DQ, IQ, OQ

Practical measures

  • Hygienic Design
  • Material management & traceability
  • Continuous quality assurance
  • Deviation management
  • Project and process management
     

During the manufacturing phase, quality is ensured through the design and production of the equipment in accordance with the principles of Good Engineering Practice (GEP). Qualified and regularly trained employees ensure the professional execution of all project stages.

Continuous quality controls throughout the manufacturing process ensure that all components and functions meet the specified requirements. Documented production data provides transparency and ensures a reproducible manufacturing process.

BEHN + BATES ensures the long-term safety and integrity of the products manufactured by combining technical, organizational, and quality assurance measures.

 

By combining GEP-compliant engineering, systematic functional testing (e.g., FAT and SAT), and continuous monitoring, BEHN + BATES ensures process reliability, high equipment availability, and the consistent fulfillment of agreed performance requirements throughout the entire lifecycle of the plant.

 

Cleaning

- Accessibility
- Dry cleaning
- Design principles in accordance with DIN EN 1672-2

Sampler

- Closed-system sampling

Food safety

- Regulation (EC) No. 1935/2004 on food contact materials (FCMs)
- Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food
- 21 CFR Part 177 – Indirect Food Additives: Polymers (FDA regulations for food-contact materials)

Production data

- Data exchange with the customer’s control system
- Reporting

Automation

- Audit Trail
- Back up 

Packaging

- Material suitability for bag packaging

Suitable environment

- Defined containment
- Enclosure of filling area, bag storage etc.

Weighing system

- Weight accuracy
- Product quality
- Reproducibility
- Documentation

Detection

- Detection during the filling process

Detection

- Detection of metal contaminants in the filled bag

Checkweigher

- Determination of bag weight
- Comparison with the target value
- Control of the filling process

QUAT2RO SealCheck

- Detection of unsealed bags

Labeling

- Bag labeling
- Printer
- Laser

Reject handling

- Metal detection
- Underweight/overweight
- Unsealed bag
- Labeling error

Labeling

- Full pallet labeling
- Batch identification, product and production data
- Traceability

Hygiene Risk Assessment (HDRM)

- Risk assessment based on FMEA (Failure Mode and Effects Analysis)

Verification documents

- Test certificates for materials used (FCM - Food Contact Materials)
- Declarations of conformity
- FAT/SAT
- Employee qualification

Sie haben Fragen?
Wir helfen Ihnen gerne weiter:
BEHN + BATES
BEHN + BATES
A HAVER & BOECKER BRAND
Robert-Bosch-Straße 6
48153 Münster