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All publications for the rubric Production & Procedure

Even smaller medical products, such as guide wires here, can be densely packed and economically cleaned using the new LPW technologies. (Photo: iStock)

18.06.2019
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Buildings & Rooms

Precision cleaning of the future

Well equipped for the new MDR

In a few months, the new Medical Device Regulation (MDR) will come into full force. The regulation places greater emphasis on traceable processes to ensure the quality of medical products. The question of whether the product also works as promised is given significantly higher priority. This also im…

Pajunk GmbH develops and manufactures various medical technology products. At the headquarters in Geisingen, Baden-Württemberg, a new production and logistics center has been built, featuring a cleanroom of GMP Class D, covering an area of 1,015 m². (Source: bc-technology GmbH)

Various work steps are carried out in the new cleanroom: These include, among others, the production of products for biopsies and anesthesia as well as testing and packaging processes. (Source: bc-technology GmbH)

Various work steps are carried out in the new cleanroom: These include, among others, the production of products for biopsy and anesthesia as well as inspection and packaging processes. (Source: bc-technology GmbH)

Some components are manufactured using the plastic injection molding process. However, production in the cleanroom has the disadvantage that the machines generate a lot of heat, which results in high energy consumption due to the installed air conditioning units. Therefore, bc-technology, in collaboration with the injection molding machine manufacturer, developed a concept that allows the machines to be integrated into the cleanroom wall without the development of unwanted particles. (Source: bc-technology GmbH)

The injection molding machine is located in the black area of the new production and logistics center. However, it can be loaded and unloaded from the cleanroom. For the injection area, a horizontally flowing filter fan unit (FFU) was attached to the housing of the injection molding machine as a protective zone, ensuring that the components are always kept under cleanroom conditions. (Source: bc-technology GmbH)

During the planning of the cleanroom, bc-technology had to consider Pajunk's requirement that machines can still be connected afterwards, which are to be put into operation at different times and independently of each other.
(Source: bc-technology GmbH)

In the visitor corridor area, the cleanroom features a full-height, large-area glass wall. (Source: bc-technology GmbH)

03.04.2019
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Buildings & Rooms

Cleanroom solutions for the manufacturing of medical technology - sophisticated concept allows for the subsequent installation of additional machines

A clean affair: Integration of injection molding machines into the cleanroom wall reduces energy costs and prevents particle ingress

Since the 1960s, Pajunk GmbH has been developing and manufacturing various products for medical technology. To prevent contamination by germs and particles, production must take place in cleanrooms that meet the high standards of the EU-GMP guideline. However, the production of components for biopsy…

The 560 sqm large CleanRoom CleanMediCell® provides plenty of brightness with large windows and LED lighting.

In the ISO Class 8 cleanroom, 2.5 billion individual parts are handled annually.

An enclosure with a laminar flow attachment supplies the product with pure air during the injection molding process.

The pipette tips manufactured in the cleanroom are used, among other things, for DNA analyses.

12.03.2019
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Buildings & Rooms

Pipettes from the cleanroom

Hamilton is investing in a modern manufacturing facility in Domat/Ems. The centerpiece of the four-story new building is a 560 sqm cleanroom, where 2.5 billion pipette tips are produced annually under controlled conditions.

The Hamilton Group is a leader in the development and production of liquid ha…

Depending on the requirements, the cleanroom experts offer a special laser protection partition system, laser safety curtains, or PVC cleanroom curtains as lateral enclosures. The appropriate protective enclosure is determined for each application in close consultation with the customer and in accordance with the applicable standards DIN EN 12254 and DIN EN 60825. (Source: bc-technology)

To ensure a clean environment without contamination risk when working on optical tables, laser cabins can be used. These are offered by bc-technology in the company's typical modular design, allowing them to be easily adapted to the specific requirements of the customer. (Source: bc-technology)

The compact laser cabins are qualified according to DIN EN ISO 14644-1 and achieve at least cleanroom class 5 through the principle of turbulence-free displacement airflow over the optical table. In the area around the optical table, at least ISO class 6/7 is achieved, thereby minimizing the risk of contamination by personnel. (Source: bc-technology)

11.01.2019
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Buildings & Rooms

Optics and laser technology, manufacturing

Flexible and mobile: Cleanroom laser cabin ensures technical cleanliness during optics or laser production

Products manufactured on optical tables are often extremely particle-sensitive. Even the smallest dust particles are enough to negatively affect the quality of the process or product. For a clean working environment without contamination risk, laser cabins can be used. bc-technology offers these in…

Micro-injection moulded medical components

Cleanroom solution with docked injection molding machine

In the cleanroom CleanCell4.0®, the finished parts can be removed directly

The injection units with the high heat loads remain outside the fully glazed cleanroom

11.01.2019
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Buildings & Rooms

Micro injection moulding in a cleanroom - New machine interfacing concept

Micro-injection moulding processes enable precise and cost-effective production of the smallest plastic components. In order to meet the highest demands on product safety and quality, the production of medical products usually takes place in cleanrooms. Stamm AG has invested in a new cleanroom with…

09.01.2019
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Buildings & Rooms

on February 26, 2019 in Mengen

Cleanroom Experience Workshop

Learning by doing: Three companies pool their expertise in an experiential workshop and let visitors experience cleanroom technology up close

Especially in cleanrooms for medical technology, it is crucial that the increasingly complex systems and components are precisely coordinated. Accordingly, the…

Image 1: Cleanroom zone concepts (onion shell) according to ISO 14644: Complex room design with high effort in operation, costs, monitoring, and time.

Image 1: Cleanroom zone concepts (onion shell) according to ISO 14644: Elaborate room design with high effort in operation, costs, monitoring, and time.

Image 2: Class D insulation solution in A.

Image 4: Isolator Cross Section and Airflow using the example of an Ortner Aseptic Isolator

Image 5: Isolated Cluster System with 6-Axis Robot

18.12.2018
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Building technology

Ready for the future: Insulators in the era of Industry 4.0

In isolator technology lies enormous potential: it can revolutionize cleanroom technology in certain areas and thus bring about significant improvements. It is essential to have the courage to interpret conservative regulations innovatively. Only then can isolator technology realize its full potenti…

18.12.2018
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Furnishing & equipment

Re-traumatization atmosphere at every location in the laboratory and workplace

The CleanBoy® Cleanroom Station from Spetec GmbH is now also available in various sizes as a table and as a freestanding unit. The working surface ranges from 0.37 to 1.12 sqm, with widths from 0.6 to 1.8 meters. This allows cleanroom conditions to be created easily and cost-effectively. These cond…

Fig. 1: Typical use of foil bags in a cleanroom production at Röchling-HPT.

Example: Cleanroom bag for primary packaging

Example: Cleanroom bag for pharmaceutical products / API

12.12.2018
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Production & Procedure

Cleanroom-compatible plastic packaging for protection against contamination

From the cleanroom for the cleanroom

Preventing contamination is one of the main concerns of risk analyses related to the cleanroom environment. All factors must be examined for their respective contamination risks. Packaging plays a special role here because it serves as a primary packaging that directly contacts the product, and hand…

10.12.2018
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Buildings & Rooms

Successful Technology Day for the inauguration of the new company location in Frickenhausen

On the occasion of the opening of their new branch, the managing directors of bc-technology GmbH invited to the first Cleanroom Technology Day in Frickenhausen.

The main theme of the day — "Cleanroom Technology in the Environment of Medical Device Manufacturing" — ran like a red thread throughout…

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