GMP - Good Manufacturing Practice
At BEHN+BATES, Good Manufacturing Practice means that all filling and packaging solutions are engineered to support validated, hygienic production processes in the food, baby food, and pharmaceutical sectors. Machine designs follow recognised GMP and hygienic design principles, with smooth, easily cleanable product-contact surfaces, minimized dust and residue build-up, and options for cleanroom-compatible system concepts. This enables customers to integrate BEHN+BATES equipment as a compliant packaging step in GMP-controlled production lines, ensuring safe, contamination-free bagging of sensitive powders and granulates.
At BEHN + BATES, quality requirements are implemented through the targeted avoidance and control of contamination risks within the machine and the installation environment. This is based on application‑appropriate material selection, good cleanability, and defined cleaning, detection, and containment measures. As a result, safe, reproducible, and GMP‑compliant operation of the machine system is ensured.
Safety compliance at BEHN + BATES is ensured by full traceability of all materials used and by clear identification and complete documentation of all components and manufactured products. Documentary evidence is available for all materials and components used, supported by an established supplier management system. During machine operation, the unambiguous identification of each batch is a central focus. Through traceable labeling, systematic sampling, and risk‑based identification of critical points, product quality remains fully controllable and traceable at all times.
At BEHN + BATES, consistent and correct functionality is ensured through reproducible and fully documented processes. This is based on Good Engineering Practice (GEP)‑compliant working methods and clearly defined functionalities of the systems used. During the Factory Acceptance Test (FAT) and, if required, through systematic qualification, it is verified that the system is suitable and reliably performs its intended functions. During ongoing operation, sampling systems and weighing systems support continuous monitoring of process accuracy. At the same time, the audit trail ensures that all relevant steps are transparently documented. In this way, the functionality of the system remains verifiable and controllable at all times.
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
48153 Münster