Do we still need a classic mock-up model as an ergonomics study for an isolator these days, with all the technological progress at hand? We strongly believe so.
While the debate about the role of digitalization has reached all industries, we are taking a closer look at what is essential for the design of an isolator for the pharmaceutical industry for the safe handling of highly potent substances. After the initial design engineering phase, the project actually begins with a model crafted from wood as part of an ergonomics study (aka mock-up). Users and our engineering experts get together live to assess and optimize the required functionality of the planned isolator from an ergonomic perspective. Criteria such as accessibility, handling of weights and the working environment are considered, and which are crucial for the safety function of the isolator and therefore the operator’s protection.
We took this textbook approach as an opportunity to show a rather unusual exhibit at the show: a combination of a classic wooden model AND a stainless-steel isolator, functional in essential parts and key elements incorporated as originals and with final materials, including negative pressure – to provide attendees the real “touch & feel.” The haptic feeling of working with gloves embedded into a glass pane provides an authentic experience and conveys the feeling of the final product. Our operable exhibit serves as a bridge between modern technologies and the traditional principles of engineering in machine design and construction: the combination of both demonstrates the way from the first ideas to the perfect solution.
Our conclusion
A mock-up as an ergonomics study enables those involved to iteratively develop the optimal design. The physical interaction and the authentic experience provided by the wood model therefore remains the measure of all things for the ideal and application-specific contain-ment isolator. CAD and software simulation can support but cannot completely replace the hands-on adventure.
On ACHEMA 2024 we show with our exhibit, how an isolator project evolves from the „first idea to the perfect solution“. A very special thank you to our partners castus®, ChargePoint Technology, METTLER TOLEDO Life Sciences and Systec & Solutions GmbH for their high-end equipment which we have proudly installed onto our ACHEMA 2024 exhibit.
Portfolio Information
• Isolators – for occupational, environmental and product protection
Negative pressure isolators for the occupational and environmental protection, for OEL levels < 0,1 μg/m³ for the handling of oral solid dosage products (OSD)
ART isolators are custom and application-specific designed for the safe and reliable work on and with highly potent substances (HPAPI). Starting in the chemical production area of the pure, active pharmaceutical ingredients (mostly in an ATEX atmosphere) over product handling such as e.g. dispensing into IBC containers in the pharmaceutical manufacturing up to dedicated applications in manufacturing processes such as e.g. milling, blending, and compacting of oral solid dosage forms. In some cases, a safe stand-alone system is required such as e.g. an IPC isolator or a development isolator in the lab.
The substances handled inside the ART containment system are often sensitive to moisture, oxygen or light and require certain processing conditions which are addressed by ART engineering solutions. Typical process machines such as lab scale tablet presses or mills are sometimes not containment-ready, so these process machines are modified and integrated into the isolator, or the isolator is literally built around the process.
To ensure the safety of the most critical positions, namely the interfaces between the isolator and the process room, ART uses the best suitable transfer technology for the application, such as e.g. Rapid Transfer Ports (RTP) or custom-made transfer ports.
Cleanability is a key factor which is taken very serious during the design phase and standard at ART. A typical project at ART gets going with a wooden mock-up model of the isolator as part of an ergonomics study. Here, the users meet with our experts to test and optimize the functionality of the planned isolator live from an ergonomic perspective. Criteria such as accessibility, handling of loads and the working environment are considered as they are crucial for the safety and protection of operating personnel. The mock-up enables to iteratively develop the optimal design of the system for the specific application. The physical interaction and the real experience of the wooden model is the first milestone for the optimal design of an insulator. The remaining engineering work is done by us.
All activities are backed up by our comprehensive offers such as e.g. our expert inhouse-training service which can also be used before delivery of the new system to train operators in all handling steps and even facilitate and support the operation staff for developing optimal handling and cleaning procedures. All findings can be leveraged and transferred to the real system and shorten the ready-for-production status significantly.
• LF cabin / LF booth (UDAF)
For the handling of bigger portions of powder product, e.g. excipients in drums arriving on a pallet with an OEB level up to 3 (with add. measures up to OEB4), the use of LF cabins is the means of choice. Under unidirectional air flow (UDAF), a physical barrier with air inflow from the process room or alternatively an air-jet barrier, both operator and environment stay safe and protected from airborne contaminants.
• LF Cabin / Booth & Safety workbench
For the handling of bigger amounts of powder, e.g. excipients in drums arriving on a pallet with an OEB level up to 3 (with add. measures up to OEB4), the use of LF cabins is the means of choice. Under unidirectional air flow, a physical barrier with air inflow from the process room or alternatively an air-jet barrier, both operator and environment stay safe and protected from airborne contaminants. Also available as „smaller version“ in tabletop style aka safety workbench, which provides similar protection through a limited access area for the operator’s arms.
