Disposable Freeze-Drying Trays for Apis or Hpapis for Lyophilization Single-Use, Self-Contained Tray

Product Description

 

Product Introduction:
The single-use freeze-drying tray is a new type of disposable freeze-dried plate developed based on the usage scenarios of traditional freeze dryers and freeze- drying processes. It is completely closed and sterile, and uses unique ePTFE membrane technology to prevent cross-contamination and flying out, and allows water vapor to be freely exchanged during the freeze-drying process.. According to the comprehensive needs of customers for customized production, to provide customers with high- quality products and professional services.

Application Usage:
Widely used in polypeptides, oligonucleotides, proteins, and API intermediates, polysaccharide and other products of the freeze-drying process research and development and large-scale production.

Main Specifications:

Two main models
RY-1	269mm*209mm*32mm total thickness 50mm
RY-2	392mm*267mm*32mm total thickness 50mm
Note: If you need other sizes, we can produce based on your request.

 

Items	Information
Main Material	Main Body: Polyethylene (PP) Bottom Membrane: Polyethylene( PE) Waterproof and breathable membrane: expanded PTFE (e-PTFE) membrane
Pore size	0.2um
Sterilization method	Irradiation sterilization
Recommended maximum filling capacity per freeze-drying tray	200-1800ml
Recommended use temperature	-80ºC~125ºC
Recommended storage temperature	Room temperature; Humidity:<65%
The general freeze-dry time is	30-40 hours(according to the customer cooperation time and freeze-dry process adjustment time)
Filling thickness	5mm-25mm
Freeze-dry products	500ml after about 25 grams of finished products(according to the customers formula form the final data)
Package	Double-layer bag packaging(one per box,10 per box)
Product shelf life	3 years

Superiority

1. Comprehensive supervision and control of manufacturing process and quality to ensure product stability and large-scale production.
2. Long-term contract and inventory of raw materials and related components to meet the supply guarantee and delivery reliability.

Requirements that the product meets

1. Insoluble particulate test (USP788)
2. In vitro cytotoxicity assay( USP 87 L-929 cells MTT method MTT method)
3. Acute toxicity test(USP 88)
4. Intradermal Irritation test (USP 88).
5. Muscle Implant Test (USP 88).
6. Sterility (USP 71).
7. Bacterial endotoxins test (USP 85).
8. Physical and chemical container test(USP 661).
9. Thermal conductivity of the carrier liquid membrane.
10. Vehicle compatibility.
11. Flatness test.

Operation Instructions

1. Place the freeze-drying tray on the plane.
2. Unscrew the valve cap from the injection port.
3. Inject an appropriate volume of product into the container according to the aseptic operation process: injection volume ≤1.8L.
4. Put the bonnet of the injection port back to the upper part of the injection port and tighten it by hand.
5. Place the freeze-drying tray in the freeze dryer for freeze-drying.

Product Collection

1. Take out the freeze-drying tray and turn it over.
2. With a sharp tool, cut the bottom of the flexible film along a corner, and be

careful not to cut into the body. The freeze-drying tray is held by the unscratched corner and tray, and the dry powder is poured into the collection bag or mixing device through the scratched corner. For the materials attached to the freeze- dried film can be slightly scraped with soft articles, do not use sharp tools to scrape the materials stuck to the film, so as not to shed the film
into the product.

1. According to the product characteristics and process requirements, the dry powder packaging or put into the next process.