GRASON is a Polish company with many years of experience dealing with the comprehensive design and production of machinery and equipment for the pharmaceutical and cosmetic industry. High standards of workmanship and detailed acceptance put us at the forefront of manufacturers of this type of industrial machinery.
A team of technologists in cooperation with the production departments and laboratories of leading manufacturers of drugs and cosmetics allows you to precisely define the needs and parameters of the designed mixers, and as a result, provide customers with only thoughtful and practical solutions.
In addition to the offer of ready mixers, we also help in the selection of appropriate transport methods and sending finished products to packaging and bottling machines. Thanks to this, the customer can enjoy comprehensive service at every stage of cooperation.
Standards and credentials
All devices and their accessories are designed according to the individual needs of the customer. They also meet the requirements of technological processes in accordance with the directives and standards applicable to the manufacturer and are adapted to GMP guidelines and FDA regulations.
- 2006/42 / WE - the machinery directive
- 2014/35 / EU - LVD low voltage directive
- 2014/30 / EU - Magnetic Compatibility Directive
- 2014/34 / UE - ATEX directive: devices for operation in potentially explosive atmospheres
- 2014/68 / EU - PED pressure directive
- 2000/14 / EC - noise emission directive
- Declaration of conformity of machines in the EU with the CE mark
- FAT and SAT acceptance and qualification tests with documentation of IQ, OQ and DQ validation
We visualize and design our devices in CAD 3D technology using the CAD Inventor® program.
All devices have the EC / EU declaration of conformity and receive the CE mark, as well as FAT, SAT, IQ, OQ and DQ acceptance and qualification tests.
High standards of workmanship and detailed acceptance of devices put us at the forefront of Polish manufacturers of machines and devices.
1. FIRST CONTACT WITH THE CLIENT
A new Client is first contacted via e-mail or by phone. After initial verification of the Client’s requirements, we provide a budget bid that covers our capacities and the scope of offered work.
2. SITE VISIT
The next stage involves a visit of our specialists at the Client’s site in order to get study the mixer’s target operating location and the available utilities required to supply the machine. We are also happy to welcome the Client at our company and enable familiarization with the plant.
3. ENGINEERING WORK
After verification and concluding the contract, we commence engineering work. Each component and device proposed by us or the Client will be designed and visualized in CAD 3D using the CAD Inventor® software.
4. PRE-MANUFACTURING ACCEPTANCE
Prior to manufacturing, the proposed design must be approved by both sides. We commence further work only upon passing this stage.
5. ORDERING MATERIALS AND MANUFACTURING
The Manufacturing Department launches the material procurement process and places orders with subcontractors. Most elements are made on CNC machines – starting with laser sheet metal cutting, through bending, rolling and machining. Our designs are virtually unique and most of them are custom-tailored to the Client’s needs, which is why welding follows the manual TIG method.
When the device is in production, the Instrumentation and Control Department develops its part of the design. Control, which is the construction of a control cabinet with equipment and programming are conducted entirely in-house. Developing the software and touch-panel visualization is not limited to applying ready-made patterns but is always approved by Client and verified in line with the Client’s demands.
7. CONNECTING ELEMENTS
The ultimate, most important stage is “hooking-up” all elements together, which is the interconnection of cooperating mechanical and electrical parts of the device.
8. DEVICE START-UP AND TESTS
The most anticipated moments are the device start-up and testing of its functions. After testing and trials, the QC Department approves the mixer for further commissioning work.
– surface roughness tests,
– pressure and tightness tests, if required,
– VT2 100% visual inspection of welding connections,
– operating temperature accuracy test,
– control functional tests.
All tests and trials are conducted using measuring instruments legalized and calibrated by a third-party laboratory.
9. TECHNICAL ACCEPTANCE AND TRAINING
After successful testing, we invite the Client to participate in the technical acceptance and verification against the placed order. We conduct FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) at the Client’s premises. They are aimed at the functional verification of the mixer and its system against the assumptions. By default, we train the technical personnel that will operate the device.
10. IQ AND OQ QUALIFICATIONS
In the case of pharmaceutical plants, after successful FATs and SATs, we shall commence IQ Qualification (Installation Qualification), which is the confirmation of the correct installation and an approval of element conformity with the requirements and design, followed by Operation Qualification (OQ), which involves checking the correctness and functional accuracy of the device and its components.