Do you manufacture products for point-of-care testing, and do you wish to optimize your production processes and plants? Are you currently developing a new product for point-of-care testing and have many questions regarding the manufacturing process? Do you need to implement a pilot production facility for FDA approval, or are you seeking a solution for the industrialization of your production? Rychiger would be delighted to put its development competence at your disposal.
We are experts in technologies for the filling of reagents, and the sealing of special containers for the healthcare industry. We know all about the requirements that point-of-care testing (POCT) kits must meet and assist you in devising a manufacturing solution for your highly complex products – from conception to serial production.
POCT – when time is of the essence
Point-of-care testing, also known as bedside diagnostics, is the method of choice when time is precious, for instance in intensive care units, operating theaters and emergency rooms, where doctors need to act quickly, but cannot afford doing this without accurate test results.
Point-of-care testing is also a popular option in primary care facilities, clinics and pharmacies where POCT equipment is already in place. These devices are easy to operate and cost-effective, while returning accurate, lab-standard results within minutes. Thanks to POCT, doctors and other medical professionals are able to diagnose conditions must quicker to start treatment without delay. Point-of-care testing not only save lives but also improves patient flow.
Each point-of-care test method normally requires a special analytical device into which a POCT cartridge and a sample taken from the patient are placed. The entire analysis is then performed by the smart cartridge in conjunction with the analytical device, doing away manual lab processing.
For accurate results, the equipment must be safe and easy to use right at the bedside. This requires high-precision reagent delivery and optimized packaging. Where the two go hand in hand, users cannot go wrong.
Close to the patient
POCT devices are also found in primary care clinics and pharmacies. They allow for efficient health management, as doctors and patients are able to discuss the issue at hand based on up-to-date test results, so that treatment can start without delay. For intensive care treatment, dialysis and anesthetics where medics must make quick, diagnosis-based decisions, the main benefit of point-of-care tests is speed. Point-of-care testing kits are already available for many pathogens, autoimmune diseases and kidney function levels, so that rapid diagnoses make prompt intervention possible.
Other POCT applications:
- Small blood count / hematological tests: The hemoglobin level (Hb value) and the white blood cell (WBC) count reveal a lot about the general state of health of a patient. Other valuables indicators for a diagnosis are the red blood cell (RBC) count and the platelet count. Using special POCT devices, doctors can now obtain a small blood count right at the bedside and thus decide quickly on the next treatment step, as it is no longer necessary to send a sample to the lab.
INR analysis: INR stands for international normalized ratio and is a laboratory measurement to detect blood clotting problems. Prothrombin time (PT) is a blood test that measures how long it takes blood to clot. This test is routinely performed at the point of care in order to monitor the treatment with anticoagulants.
- Blood glucose testing: People who suffer from diabetes need to constantly monitor the glucose level in their blood. POCT devices enable medics to detect potential complications at an early stage so that a suitable treatment strategy can be drawn up.
- Diagnosis of infections: There are few conditions that require more rapid intervention than infections. With immunological and nucleic acid tests performed at the point of care, the pathogen causing the infection can be quickly identified so that effective treatment can commence without delay.
Solutions for complex applications
POCT methods vary greatly as regards their degree of automation. Certain tests need no automated equipment, and the results are read visually. Other methods require special automated analyzers and POCT cartridges. These cartridges are placed together with the patient sample in the analyzer, and contain highly complex assays that react with the patient sample. The cartridges handle all processes that are normally performed in the lab. This however means that faulty cartridges are likely to return incorrect results, with potentially fatal consequences.
Manufacturers thus face the challenge that their products must be 100% free of defects at the point of use. To achieve this, they must invest in advanced and highly reliable production technology. Rychiger knows all about these challenges and assists you in finding a tailor-made solution for your product.
As a global leader in filling and sealing technology, we device GMP solutions for the placing of highly complex assays in user-friendly POCT cartridges.
For every project, our team of experts bundle their experience and know-how to come up with an optimized solution. Thanks to our competence in the development of new technologies and processes, we are able to bring your project to fruition. Depending on your specific requirements, we might even have tried and tested modules ready for you. If not, we come up with a tailor-made solution for your product, designed for seamless integration into one of our machines.
As hygiene and process safety are of course major concerns, we offer machines that are easy to clean so as to minimize the risk of contact contamination by operating staff.
From conception to serial production
Are you about to embark on a new POCT project? Or do you wish to expand your roll-out capacity for an existing product?
Whatever the task you are facing, we will support you as your automation partner. We help you solve process- and production-specific problems, assist you in evaluating the feasibility of your approach and support you in setting up a pilot production line for FDA approval.
Rychiger is of course also your reliable partner when it comes to industrialization of your production, as we design optimized machines that meet your specific requirements.
Our tailor-made solutions range from semi-automated processing modules to fully automated production lines with high output rates.