Which solvents can I use with the membrane?
The membrane material is expanded polytetrafluorethylene (ePTFE), that means nearly all solvents are suitable. You only need to be careful in case your solvent has a high percentage of alcohol, as alcohol with concentrations higher than 20 % can wet the membrane and eliminates the hydrophobic characteristic. However, even if the filled liquid does splash the membrane and it loses the hydrophobic characteristic, it will dry fast and the hydrophobic behavior will return again within minutes.
Do the products come sterile?
No, not yet. The membranes and bags are autoclavable at 121°C for 20 minutes. We recommend maximum 5 cycles, this is just for the case, that your cycle will abort, and you need to repeat it. You can also use hydrogen peroxide or ethylene oxide for sterilizing our membrane and bag products.
How about Gamma irradiation or E-beam?
Our membrane is not suitable for Gamma irradiation as this decreases its stability.
How can I fill and unload aseptically?
You need to fill the container or bag under a laminar flow clean bench and close it there. If it´s closed the membrane acts as a sterile barrier. Your product is protected against contamination just after you closed the container or bag. After that you take it to your freeze dryer and theoretically your freeze dryer can be placed anywhere. You are still capable to keep aseptic conditions. The unloading or harvesting goes in reverse order under the laminar flow again.
Does the membrane still perform as barrier after getting in contact with my product?
Yes, that´s no issue. We have done tests filling a placebo solutions directly into a bag and freeze dried the closed container. The membrane had direct contact with the product during the complete cycle and it worked very well. We are developing a similar concept right now and will bring it to the market soon.
Does Lyoprotect have an impact on the freeze-drying cycle?
From a scientific point of view, I need to say yes, the membrane barrier does have an impact and you can measure it. But from a practical point of view, I would say the impact is very small and negligible compared to other factors. The porosity of the dry cake is the main resistance for vapor escape at the sublimation front. I am happy to say, that I hear from my customers, “yes, you are right, it´s working.”
Which certificates regarding quality does Teclen offer?
We offer certificates of material for all used materials. Also certificate of origin is available on request.
Can I get a MOC, COA and COC for the Lyoprotect® products as our quality department requires the details?
Yes, we can provide the required documentation and will also answer in detail your supplier questionnaires. Since October 2021 our quality management system is ISO 9001:2015 certified and we will proceed installing and documenting even higher standards. Since a couple month we have a dedicated quality manager.
How long is the shelf life?
Two years for most plastic products like membranes and bags. Other plastic products have a longer shelf life up to 5 years. For hardware like aluminum or stainless-steel trays and cups I have not defined any shelf life. These parts are built on request and therefore customers start to use it after shipment. The lifetime of a stainless steel tray is minimum 5 years, because I have sold my first customized tray 5 years ago and the customer is still buying the adequate membrane and gaskets.
Does the membrane hold back bacteria, and can you proof that?
Yes, the membrane can hold back bacteria and we performed an according validation test, which is available on request.
Can I reuse the membrane and how often can I use it if yes?
The membrane is designed as a single-use product. A cleaning validation (avoidance of contamination, cross-contamination) is not possible in my opinion.
What Pore size does the membrane have?
I see the pore size as Teclen IP. Moreover, the pore size alone is not a good measure, as we are not talking about liquid filtration. We protect API inside a tray or drug products inside a vial against contamination during lyophilization. It is vapor during primary drying which is crossing the membrane. Vapor behaves as gas, and this is different to liquids.
In which sizes do you offer the bags?
The bags are customizable, and we calculate the size individually for each application. We have learned that the requirements like shelf dimensions and tray/vial sizes are very different. This is why we do not offer standard bag sizes.
Can I use the bag for vacuum drying as well?
Yes, that´s also possible.
I´m planning a GMP production. Are your products approved by the FDA/EMA?
Neither FDA nor EMA offer approval of supplier products itself. It is up to you to build a manufacturing process for your API or drug product, which meets the requirements of the regulatory authorities. This is feasible with Lyoprotect® and we are happy to support our customers with all relevant documents.
Can you provide further information regarding material compatibility?
The membrane consists of ePTFE, which is very durable and resistant to most solvents, including acids.
Do you have data about extractables and leachables?
Not yet, but we have it on our to do list, lately when our new product, a single use tray, becomes available. Actually, there isn´t a long-lasting direct contact between API or drug product and plastic. A direct API contact does only exist by accident when you splash during filling or transportation. If you use our Lyoprotect® bag for vials, you always have glass in between. Therefore, you can argue leachables are not necessary and that means for me extractable are not necessary at the current stage. But I agree it is a different story when a long-lasting direct contact is part of the concept.
What about endotoxin values for your products?
We determine the values on customer request only. Still we are working on a program to specify a value as product claim for all shipments – stay tuned.
The prices for the membranes and bags seem quite high…
The prices do not only include the material and labor costs, but also the costs for development and most importantly quality. Especially if it comes to GMP. Our customers require a lot of certificates and documentation about the suitability of our products to serve their GMP process. We take this responsibility very serious and work hard on the evaluation of our used materials, our manufacturing process and the according documentation.
* United States Pharmacopeia