Company: Biorep Technologies, in partnership with the Cure Alliance. ISO 13485 Certified and FDA registered full-service developer that works in partnership with healthcare pros and
researchers around the world to improve people’s quality of life.
Industry: Medical
Services: CNC Machining, Annealing, Polishing
Material: Ultem 1000 Polyetherimide
Color: Natural (amber)
Quantity: 3 sets of 3 parts each
Lead Time: 6 days
Table of Contents
"The level of support that our account manager Erik Must provided for these stem cell isolator chambers to support the COVID-19 clinical trials was outstanding. What would normally take 4 to 6 weeks was manufactured in six business days."
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The Project Brief: Manufacture a Stem Cell Isolator Chamber
Every second matters in medical research — especially during the unprecedented global crisis of the COVID-19 pandemic.
To aide in this research, Biorep Technologies, along with a group of medical professionals and engineers, developed a stem cell isolator chamber and entrusted Star Rapid with the production of its components.
A custom components manufacturer with ISO 13485:2016 certification like Star Rapid is an invaluable asset for a project like this.
The Challenge: Rapid Product Development on A Critical Schedule
To ensure timely delivery, we had to adapt our production schedule to ensure Biorep’s parts were completed in less than a week.
“The level of support that our account manager Erik Must provided for these stem cell isolator chambers to support the COVID-19 clinical trials was outstanding. What would normally take four to six weeks was manufactured in six business days.”
- Felipe Echeverri, Managing Director at Biorep Technologies
Our Approach to Manufacturing the Stem Cell Isolator Chamber—From Material Testing to Finishing
The Material Choice: Ultem 1000 to Withstand Steam Sterilization
Like other polyetherimide resins such as PEEK, Ultem is an engineering grade plastic. This amber transparent polymer combines strength and long-term heat resistance.
The main benefits are:
- Chemical resistance to alcohol, acids, and other substances
- High mechanical strength
- Stiffness under elevated temperatures
- Resistance to stress cracking
Ultem is much stronger and more rigid than most thermoforming plastics, so it’s widely used in the medical field. It excels in applications that require repeated steam sterilization, like the isolator chamber parts.
Although it is possible to use Ultem 1000 in a plastic injection mold, we chose CNC milling and turning for this project because Biorep only needed a few parts that needed to be produced fast while also maintaining tight tolerances.
Initiating Manufacturing
Manufacturing began as soon as we received the polymer order, and our team focused on the need for:
- Extremely fast turnaround
- Positive material identification
- Meticulous attention to detail
Positive Material Identification
Material identification is crucial to ensure that only high-quality raw materials are used. This is important in every kind of project, but even more so for healthcare and medical equipment, which are subject to strict quality and safety guidelines.
The Ultem 1000 was tested with a Polymax gun, which emits a laser that compares the molecular signature of the sample with a database of common resins. CNC machining started only after confirmation that the Ultem was fully qualified.
CNC Milling
Initially, the parts were roughed out using a combination of CNC milling and turning. The goal was to remove large amounts of material from the workpiece quickly to shape it close to the desired form.
For projects like this, CNC milling offers several advantages, including minimal setup times, low initial investment, and high accuracy.
The separator screen was rough-milled on our five-axis CNC milling center, which allowed us to efficiently machine all the beveled faces on the grid.
CNC Turning
Next, the parts were CNC turned, which is ideal for making deep holes and cylindrical shapes that require superior surface finishes.
CNC turning offers many benefits:
- Fast turnaround
- No volume limitations
- Accuracy
- Precision
- Close tolerance
- Excellent surface finishes
- No need to invest in hard tooling
Therefore, it was the perfect choice for creating the isolator chamber parts.
CNC turning centers have moveable turrets that can also machine inside diameters with undercuts using “live” tools that rotate independently of the main spindle. The lathes facilitate the removal of material, and the fine cutting tools make excessive post-finishing unnecessary.
For the main reservoir, we turned the large plastic blank down on the lathe, while also boring out the central hole.
With the major dimensions established, we annealed the parts.
Annealing
Annealing reduces the risk of the material cracking during regular use by removing internal stresses that may have been caused in earlier stages of production.
The first pass through the CNC machines left the parts with a rough surface finish and visible tooling marks, which is a natural result of removing as much mass as possible while shaping the parts.
Internal stresses are generated in the walls of the components, but annealing prevents each piece from cracking during the repeated temperature cycles that the stem cell isolator chamber will be subjected to during its regular use.
During this process, the parts are immersed in water for about an hour, the liquid is heated to boiling, and then it’s allowed to cool back to ambient room temperature.
Finally, the piece is reassembled on the lathe for a final turning. The parts are temporarily glued to a movable base to prevent damage to a relatively fragile plastic, and once they are turned, the parts are ready to finish.
The parts of the stem cell isolator chamber were then ready for finishing.
Finishing
The dimensions of the parts were measured, then each component was sent to our model shop, where it was finished through wet sanding and polishing. Both processes not only help aesthetics, but they ensure the parts function exactly as they should.
The stem cell isolator chamber parts required a high gloss finishing, so the first step was to wet sand them to create the final surface effect and prepare the surface for the next stages.
Our professionals carefully worked on each space using black markers to indicate which areas hadn’t been touched.
To make the pieces as optically clear as possible, we followed up with surface polishing and buffing. This quality control step ensures that every area is free of scratches, tooling marks, and other imperfections.
The surface of the isolator chamber needs to be as clear as possible, for two main reasons:
- To make the components easier to clean.
- To better facilitate handling the biological material that will be in contact with each piece.
The final product was three glassy isolator chamber sets with three pieces each.
Rapid Delivery
The entire production was finished in six business days, with the parts being sent for field tests shortly after. Under normal conditions, manufacturing parts for projects of this nature takes weeks to be completed.
But at Star Rapid we could speed things up because we have:
- Our robust network of suppliers, capable of delivering raw materials without delays.
- Deep technical knowledge and decades of expertise necessary to develop the lean manufacturing system we have today.
- Clear and transparent communication between account managers, production and model shop teams, and the technical leads at Biorep Technologies.
As a result, we adapted our schedule, streamlined our production efforts, and Biorep received their parts quickly and in compliance with all the necessary guidelines for their research efforts
As a result, we adapted our schedule, streamlined our production efforts, and Biorep received their parts quickly and in compliance with all the necessary guidelines for their research efforts
The use of stem cells as a clinical tool for COVID-19 research was pioneered by Biorep and The Cure Alliance, along with their Italian counterpart Fondazione Cure Alliance ONLUS.
The completed stem cell isolator chamber helped the team led by Dr. Ricordi prove that stem cells can improve the quality of life of COVID-19 patients. Their studies showed potential to increase survival rates in severe cases of the disease and to reduce recovery time.
What’s the Timeline for Your Next Project?
Each project at Star Rapid is managed with the same enthusiasm, speed, and excellence at every stage of production.
We understand that each endeavor has its own peculiarities – unique designs, steps that are not always clear from the start, and hard deadlines. That’s why our international team is prepared to deliver tailored solutions that offer quality, transparency, and economic advantage.
Get started on your next product development journey and send your CAD files directly to receive a free quotation and project review from our engineering team.
