Country: Ireland
Application: Initial weighing station in the weighing workshop
Industry: Pharmaceutical industry
Year: 2005
Product: IF Pharmaceutical Production Line Flat Scale
When a global leader in the pharmaceutical industry decided to plan and build a new production plant, Sartorius participated in the drafting and use of a high-performance weighing station equipped with an absolutely dust-free environment. The tailor-made solution for the customer was produced in cooperation with Sartorius ’Dublin subsidiary and the engineering team of the Göttingen flagship factory. This is a solution for trusting the company and establishing a new enterprise benchmark.
The company above is the largest research and production company in the world in the production of medicines and health products. It has nearly 100,000 employees worldwide and has representative offices in more than 100 countries.
It is required that the purpose is to weigh medium-sized bulk containers with a net weight of 500 kilograms by means of weighing scales. In addition, it weighs 1,000 kilograms in containers. Floor scales need to meet the strict requirements of the pharmaceutical industry in clean rooms
These scales need to be particularly ergonomic and integrated with existing procedures. The additional task is to significantly reduce the cleaning time.
Drug manufacturers are looking for high-performance scales for 6 weighing stations. . .
-The minimum sample size for performance and continuity (recorded by DKD certificate)
-Meet the requirements of the US FDA in terms of materials, surface roughness, property and cleanliness.
-Greatly reduced cleaning time in production
-Comply with the requirements of NIOSH (National Occupational Safety and Health Research Institute) in operation and cleaning procedures
-Includes equipment qualification documents in delivery
-Manufacturing execution system that can be incorporated into this process
-The requirements for the realization and optimization process are very close to three quarters (transport routes, material handling and weighing reliability)
-Suitable for explosion-proof, comply with ATEX certification regulations
The mutually derived solutions are based on the original Sartorius "pharmaceutical production line" platform scale product line. They have developed key factors for local hygiene, health and safety levels
Amend Sartorius's customer consultants to participate in customer project meetings to discuss how to modify the "pharmaceutical production line" platform scales to meet the special conditions of the weighing cabinet. The meeting came up with the most important standards for safe operation and suitable clean rooms.
Cleanroom suitability includes not only materials and surfaces. In short, the single factor operation (conforming to NIOSH) and reducing the conventional cleaning time by about 10% are important factors for dust removal. These reductions do have a positive impact on OEE (Overall Equipment Benefit). Together, we found an optimal solution for our customers.
These optimizations incorporate URS (User Requirements Specification)
According to URS, the first step is to build an initial model. The installation was completed within the agreed time and under the designation of the designated project engineer.
Factory acceptance test, FAT
The customer's engineer in charge of the project visited Sartorius' production facility in Göttingen. At this stage, the FAT (factory acceptance test) of the original model is implemented.
Before the visit, the two parties drafted a test agreement that meets the User Requirements Specification (URS). All results and opinions were formally recorded.
The personal testing phase includes:
-Proof of accurate weighing through calibration measurement
-The minimum initial weight is certified by the DKD certificate (in this case, together with the manufacturer)
-Proof of material grade, surface roughness and equipment size
-Proof of numerical lift required for lifting weighing platforms that meet NIOSH requirements.
-Review process design
The original FAT model passed the test with great success. The actual measurement involved in the first meeting provided an opportunity to collect more practical experience in the operation of weighing scales. On this occasion, more improvements were made, some of which have been incorporated into the final version of production.
"Satorisi provides very active experience support, flexible and autonomous, they are familiar with our needs, difficulties and constraints in the production process. At this point, considering that another supplier is not willing to accept any product changes. I am convinced that we have found the best solution and the best manufacturer, "concluded the client ’s lead project engineer.
In the next step, Sartorius incorporated the modifications discussed by both parties in the subsequent SAT prototype (SAT = fixed-point acceptance test). This model is handed over to the customer for testing as the actual operating environment. As a result, a batch of Sartorius service personnel was released, delivered and installed.
Summary
Customers use this solution as a benchmark for all future installations by their companies. During the planning process, both parties were very satisfied with the constructive and early participation of the suppliers. This ultimately resulted in an optimized design of the scale, but also improved the efficiency of the weighing station and reduced cleaning work.
This successful cooperation puts Sartorius Germany among the top suppliers. Even during the follow-up actions after installation, any new problems are recorded at the same time. This trust further generated and successfully carried out the project.
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