Double layer packaging sterility test closed canister SS304 needle
50mm diameter filter
How does contamination occur?
There are many sources of contamination in the production of
biopharmaceuticals. This includes raw materials, personnel,
equipment, and manufacturing environments. Regulators will provide
guidance to reduce the risk of contamination with bacteria or
fungi, including the use of raw material disinfection techniques,
ensuring sterility, and conducting GMP. However, despite these
precautions, the risk cannot be completely eliminated. Therefore,
sterility must be regularly tested during the manufacturing
process.
Determination of sterility
Sterility testing guidelines are found in various pharmacopoeias
around the world, including the US Pharmacopeia (USP) and the
European Pharmacopeia (EP). IHC has adjusted this guide (3). The
infertility test conducted by Sartorius STEDIM is a GMP
specification, followed by EP (2.6.1. Infertility) and USP
(<71> Sterility Test).
Characteristics of Sterility Test Canister
Ultrasonic welding process, smooth and fast, to achieve the best
sealing performance.
High-precision rubber hoses are made of special materials with
long-lasting tension, wear resistance and stress resistance to
ensure maximum detection.
It uses medical dialysis packaging imported from the United States
to ensure the sterility of the product, to quickly retain ethylene
oxide and reduce ethylene oxide residues.
Transparent blister packaging, in line with international
standards.
Transparent composite packaging to reduce packaging waste and
reflect environmental protection
Pipe assembly lights are easier to use.
- Two layers of aseptic packaging facilitate cleanroom transfer and
reduce contamination during transfer.
- Gamma sterilization, no residue, safe and reliable, to avoid false
negative results.
- Microbial microbial retention, microbial growth (sensitivity) and
sterility testing ensure reliable and reliable results of sterility
testing.
- Filter: bubble point method, bacterial retention test.
Two layers of aseptic packaging facilitate cleanroom transportation
and reduce contamination during transportation.
Gamma ray sterilization, no residue, safe and reliable, to avoid
false negative results.
Sal 10-106, in line with the requirements of the 2015 Chinese
Pharmacopoeia radiation sterilization method.
The ultrasonic welding process ensures air tightness and pressure
resistance.
ll 100% passed the airtight performance test.
Microbial microbial retention, microbial growth (sensitivity) and
sterility testing ensure reliable and reliable results for
sterility testing.
Screening: bubble point method, bacterial retention test.
Check the stability test: the cultural period is 14 days.
parameter
| Schematic Diagram | Model | Inspection Style | Packing Spe. |
 | Py220C | Glass Bottle Large Volume Injection | 72Sets/Box 18sets/Box
48 Sets/Box 12sets/Box |
| Py330C |
| Ksf220C | Glass Bottle Large-Capacity Antibiotic Injection |
| Ksf330C |
 | Apy220C | Ampoule Injection |
| Apy330C |
| Kapy220C | Ampoule Antibiotic Injection |
| Kapy330C |
 | Dgb220C | Vial Bottle Soluble Powder |
| Dgb330C |
| Kdgb220C |
Vial Bottle Soluble Antibiotic Powder |
| Kdgb330C |
 | Sdy220C | Soft Bag Large Volume Injection |
| Sdy330C |
 | Fsy220C | Insoluble Liquid |
| Fsy330C |
 | Nkf220C | Powder That Needs To Be Dissolved And Diluted |
| Nkf330C |
Direct transfer sterility test
Combination product: This method is the preferred method for
medical devices because the device is in direct contact with the
test medium throughout the incubation period. Living microorganisms
that may be present in or on the defective/sterilized product have
an ideal environment in which disinfection can be carried out,
especially for damaged microorganisms, which are caused by a
sub-lethal sterilization process. All microorganisms have
bioremediation mechanisms that can be directly transferred using
environmental conditions conducive to growth, thereby benefiting
these damaged microorganisms. The entire product should be immersed
in the test solution; for large equipment, it should be immersed in
the patient contact area; large catheters can be filled with the
test medium with a syringe before immersion; cutting the catheter
sample for complete immersion is the method of choice.
The United States Pharmacopoeia authors understand that because the
size and shape of the test sample requires appropriate
modifications, the method requires that the product be transferred
to a separate container of FTM and SCDM, and then the product
should be aseptically cut or transferred to the medium in its
entirety. Fully immersed in the test medium, USP limits the volume
of the media to 2500 ml and packages the sample for 14 days after
transfer.
