The Single Use Support freeze-thaw platforms provide reliable end-to-end solutions, such as plate freezers for the controlled freeze/thaw processes of any drug substance - either for clinical phases or commercialized bulk production.
Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.
Whitepaper Download
Being able to control the freezing behavior of bulk drug substance is the ultimate goal in Biopharma manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing, and consequently for frozen storage and shipment.
We tried to visualize Cryoconcentration by using Naphthol Blue Black as color agent. An intense blue coloration shows a high concentration of dissolved solutions. The bags frozen in the plate freezer exhibit a homogenous tinge with a white line running through the center. The bag frozen in the static freezer exhibits higher concentration levels in the lower areas.
Dark blue spots indicate a higher cryoconcentration
A homogeneous freezing, no dark blue spots are visible.
Click here to download technical product data sheets, design videos, as well as a case studies and more.
Datasheet RoSS.pFTU Lab Scale
Filesize: 0.72 MB – Mime-Type: application/pdf
Datasheet RoSS.pFTU Large Scale
Filesize: 1.78 MB – Mime-Type: application/pdf
Hybrid Freezing Brochure - Bags and Bottles
Filesize: 1.28 MB – Mime-Type: application/pdf
Whitepaper: How Controlled & Scalable Freezing Becomes Reality
Filesize: 1.77 MB – Mime-Type: application/pdf
Freeze & Thaw Scalability Guide
Filesize: 0.83 MB – Mime-Type: application/pdf
Datasheet RoSS.pFTU Mid Scale
Filesize: 0.57 MB – Mime-Type: application/pdf
Datasheet RoSS.pFTU XL
Filesize: 0.82 MB – Mime-Type: application/pdf
Whitepaper: Scalable Freezing & Thawing of Pharmaceutical Bulk
Filesize: 0.73 MB – Mime-Type: application/pdf
App Note: "Bestcellers": Controlled Filling & Freezing of Cells
Filesize: 1.48 MB – Mime-Type: application/pdf
Click here to download technical product data sheets, design videos, as well as a case studies and more.
Freeze-Thaw Platform “RoSS.pFTU lab scale” is a laboratory freezer used for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.
RoSS.pFTU is our “standard” freeze-thaw platform. It is suitable for different batch sizes and offers a fully scalable solution for medium-sized and large batch volumes.
Rapid freezing achieves a far more homogeneous freezing result. Not only can this save 100% of the cells, it’s also way faster than any established freezing processes to date. Single Use Support has developed a so-called “Plate Freezer” for all batch sizes, which makes fast freezing really easy.
In biopharma and similar industries related to the healthcare sector there is a lot of talk about the process of freezing with a pharmaceutical freezer: This process brings medical grade drug substances into a frozen state to allow for protected, safe and reliable storage and shipping at low temperature.
It depends on the drug substance at what process steps and at what temperature it needs to be frozen in order not to get degraded. The most recent accomplishments in COVID-19 vaccine clinical trials and the raised discussions of required temperature for storage in vaccine refrigerators and vaccine freezers are solely about the vaccine storage temperature after fill & finish in final syringes and vials. There will still be need to fulfill CDC requirements for ultra cold freezing to -80°C in the bioprocess manufacturing process steps ahead until the vaccine is being filled into syringes and vials for global supply.
However, the medial anxiety about freezing biopharmaceuticals to ultra low sub-zero temperatures in the -60°C and -80°C temperature range has only shown that established technologies do not fulfill high performance industry requirements and are not well-trusted yet. To date, the methods employed in research often involve traditional auto defrost and countertop laboratory freezers and cooling systems that usually are, however, not the most efficient ones.
Countless academic research labs utilize dated refrigerator/freezer combinations for flammables and freestanding chest freezers as lab freezers, often without digital temperature display or temperature alarms, and still require manual defrost. Medical-grade refrigerators (e. g. blood bank refrigerators) and medical freezers are usually equipped with thermostats that are calibrated with NIST conforming thermometers and with automatic defrost.
The utilization of static glass door refrigerators and standard solid door compressor laboratory refrigerators is responsible for up to 56 % of viral potency product loss in biopharmaceutical manufacturing. This almost incredible percentage is the result of a slow and inefficient procedure that leads to decreased temperature uniformity and inhomogeneous results.
In highly complex and technically progressive environments brimming with microprocessors and data loggers, with a focus on speed and quality, traditional pharmaceutical refrigerators and freezing processes are, generally speaking, no longer appropriate. They prove to be more and more inefficient as they only slowly drain the heat from the product, thus lacking appropriate temperature control and leading to an inconsistently frozen substance. What is needed are efficient systems based on elaborate, cutting-edge procedures that are tailored to push productivity by freezing biopharmaceutical substances evenly and without any product loss - ultra cold freezer.
Sophisticated and intelligent freezing system will have to cover three main aspects in order to meet the basic requirements of today’s biopharmaceutical industry:
These three parameters have to be considered in order for a platform to be relevant for drug substance logistics in labs and manufacturing, both for small batches and bulk production.
With RoSS.pFTU, Single Use Support has developed a freeze-thaw platform that addresses the needs of the industry and provides solutions. The system designed by Single Use Support allows for a blast-like freezing where the substance contained in RoSS® is evenly frozen thanks to the direct contact between the plate freezer and the stainless steel plates covering the container: The close contact between freezing plates and liquid substance significantly speeds up the process as it facilitates a direct transfer of the cold. Additionally, there is no ambient air that requires cooling, as is the case with traditional freezers. The homogenous outcome of this plate freezing technology not only maintains the substance’s original quality but also protects it from potential damages during shipping and thawing.
In addition to affording fast and homogeneous results, Single Use Support’s freeze-thaw platform offers additional benefits that merit its use in the biopharma and similar industries:
While blast freezers use cold air that is blasted on products that are yet to be frozen, plate freezers work via direct contact between the cooled plates and the products.
The fields of application of plate freezers are manifold, since they are able to deliver a very consistent and fast freezing process. Therefore, they are, for instance, an essential tool in biopharma industry, where the quality of highly delicate products needs to be maintained when bringing them to ultra-low temperatures.
A pharmaceutical-grade freezer is a freezer that is designed to freeze and store pharmaceutical substances – for instance vaccines – in a secure and efficient manner. In order to be able to cope with the high fragility of these products, there are several aspects in which they differ from ordinary kitchen freezers.
Medical freezers are designed to maintain set temperatures within a range of usually between -40 and 86 °C, in some cases down to -150 °C.
