Laboratory sterility test device EO sterilization ISO9001 Closed
Sterile Canister
It is important to test the sterility of biopharmaceuticals to
ensure safety. If not found, the contaminants can lead to
life-threatening infections. There were many examples in the past,
but the product was recalled because there was no guarantee of
sterility (4). It is therefore important to ensure that the test
procedures performed comply with regulatory guidelines. WINTEAM can
provide the necessary evidence for mass production of
biopharmaceuticals by ensuring that professional biosafety
professionals perform the necessary sterility tests according to
GMP standards.
Sterility testing of pharmaceuticals is required during
sterilization validation and in routine release testing. USP
requires sterility testing as a formal test to determine the
suitability of a large number of products. Understanding the need
for sterility testing to help design validation processes to
provide adequate and reliable sterility test data is an important
quality assurance issue. Sterility testing is a very cumbersome and
embarrassing process that must be performed by trained and
qualified laboratory personnel. Investigation of the failure of a
sterility test is a process that requires attention. Environmental
data and many other factors, including training and sample
difficulty.
Disposable for sterility test, all closed.
For different samples, different types of canisters.
Meet the sterility testing industry benchmark
Minimize false positives: closed filtration devices reduce the risk
of false positive results and avoid costly investigation and
possible batch loss. There are no open containers or membrane
manipulations, which could increase the risk of contamination.
Reduce false negatives: Steritest filtration devices are the right
answer to the danger that false negative results pose to patients.
Through specific membranes, unique sealing technology and optimized
device design, the unit allows efficient elimination of
bacteriostatic, fungistatic or bactericidal agents.
Easy Identification with color coding and optimized traceability.
Characteristics of Sterility Test Canister
HTY Sterility Test System is composed by SteritailinTM Closed
Sterile Canister and HTY Germs Collector which regards as “GOLDEN
STANDARD” during sterility testing for injection drugs.It passed
ISO9001 amd ISO14001 cetificates. The united use of them keeps all
process carrying out in complete closed condition, including
transfer, filter and incubate, which avoid exogenic contamination.
Accoring to different feature and package of the test sample, we
develop corresponding types of sterility test kits to satisfy the
demand on each test sample.
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 |
The USP <71> sterility test consists of two qualifying tests
that must be performed prior to sterility testing, "adaptive
testing" (promoting growth testing) and "validation testing"
(antibacterial and fungal disease testing).
The suitability test is used to confirm that each growth medium
used in the sterility test procedure will support the growth of
less than 100 viable microorganisms, which will fail if the medium
does not support the growth of the indicator organism. According to
the culture parameters (time, temperature) determined by the
method, a part of each medium batch must be specially sterilized,
and if the medium is not sterilized, the test fails.
The verification test is used to determine whether the test sample
inhibits the growth of microorganisms in the test medium.
Microbiological retention means that the microorganism cannot grow
and proliferate in the microbial medium, and the bacteriostatic
medium does not necessarily kill the bacteria; it may It only
hinders the growth and reproduction of bacteria. Each product must
be tested for validation prior to and/or during the sterility test
to determine if the media volume is valid for a particular product.
Certain medical products contain bacteriostatic and fungistatic
compounds and may require special procedures and special media for
testing. This test is similar to the suitability test described
above, but the product sample is placed in the medium along with
the microorganisms. It was compared to a control without a test
sample. If microbial growth is present in the sample and control
containers, the next step is to perform an actual sterility test
that allows for simultaneous suitability, validation, and sterility
testing.
