Country: Ireland
Application: Initial weighing station in the weighing shop
Industry: Pharmaceutical Industry
Year: 2005
Product: IF Pharmaceutical Production Line Scales
When a global leader in the pharmaceutical industry decided to plan and build a new production workshop, Sartorius was involved in the drafting and use of high-performance weighing stations equipped with absolutely dust-free environments. The tailor-made solution for the customer was produced by the engineering team of the Sartorius Dublin subsidiary and the Goettingen flagship factory. This is a believe in the company and establish a new enterprise benchmark solution.
The companies listed above are among the largest research and production companies in the world in the production of pharmaceuticals and health products. It employs nearly 100,000 people worldwide and has representative offices in more than 100 countries.
The purpose of the request is to use a floor scale to weigh 500 kg of IBCs for the transport of materials, and in addition, to weigh 1,000 kg in containers. Ground scales need to meet the strict requirements of the pharmaceutical industry in clean rooms
These floor scales need to be particularly ergonomic and combined with existing procedures. Another task is to significantly reduce the cleaning time.
Drug manufacturers are looking for high-performance floor scales for six weighing stations. . .
- Fulfillment and continuous minimum sample size (recorded by DKD certificate)
- Meets US FDA requirements in terms of materials, surface roughness, property and cleanliness.
- Greatly reduced cleaning time in production
- Meet NIOSH (National Institute of Occupational Safety and Health) requirements in operation and cleaning procedures
- Including equipment qualification documents in delivery
- Manufacturing Execution System that can incorporate this process
- The requirements for the implementation and optimization process are very close to three quarters (transportation route, material handling and weighing reliability)
- Suitable for explosion protection, ATEX certified
The solution based on mutual derivative is based on the original Sartorius "Pharmaceutical Production Line" platform scale product line. They have formulated key factors for the level of local health, health and safety
Revised Sartorius's customer advisor to participate in the customer's project meeting to discuss how to modify the "Pharmaceutical Production Line" platform scale to meet the special conditions of the weighing cabinet. The conference concluded that the most important criteria for operating a safe and suitable clean room.
Clean rooms are suitable not only for materials and surfaces. In short, about 10% of the cleaning time is achieved through single-person operation (in line with NIOSH) and reduction in the normal cleaning time is an important factor in the degree of dust removal. These reductions do have a positive effect on OEE (Overall Equipment Benefits). Together, we found a best solution for our customers.
These optimizations incorporate URS (User Requirements Specification)
According to URS, the first step is to establish an initial model. The installation is completed within the agreed time and designated by the designated project engineer.
Factory acceptance test, FAT
The engineer responsible for the project visited the Sartorius production facility in Göttingen. At this stage, the initial model's FAT (factory acceptance test) was implemented.
Prior to the visit, both parties drafted a test agreement that met the user requirements specification (URS). All results and opinions were formally recorded.
The personal testing phase includes:
- Prove accurate weighing by calibration measurement
- Minimum initial weight certified by DKD certificate (in this case with manufacturer)
- Material grade, surface roughness and equipment size certification
- Proof of lifting force required to raise the weighing platform in accordance with NIOSH requirements.
- Review process design
The original FAT model passed the test. The actual measurement involved in the first meeting provided an opportunity to collect more practical experience in operating weighing scales. On this occasion, more improvements have been made, some of which have been included in the final version of production.
"Sartoris provides very positive experience support, flexibility and autonomy, they are familiar with our needs, difficulties and limitations in the production process. At this point, taking into account another supplier is not willing to accept any product changes. I am convinced that we have found the best solution and the best manufacturer," concludes the customer's chief project engineer.
In the next step, Sartorius incorporates the modifications (SAT = Site Acceptance Test) of the two parties after discussion in the subsequent SAT prototype. This model was handed over to the customer for testing as the actual operating environment. As a result, all Sartorius service personnel released a batch, delivered and installed.
The abstract customer regards this solution as a benchmark for all future installations of his company. In the planning process, both parties are very satisfied with the supplier's constructive and early participation. This ultimately resulted in an optimized design of the scale, but also increased the efficiency of the weighing station, reducing the cleaning work.
This successful cooperation has made Sartorius Germany a top supplier. Even when the post-installation follow-up action is taken, any new issues are filed at the same time. This trust further generates and successfully carries out the project.
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