High Reliable laboratory sterility test kits ultrasonic welding
SAL≤10^-6
Sterility Test Canister
3. Flow path sterility test
This sterility test method is suitable for products with hollow
tubes (such as infusion sets and infusion sets) that are
inaccessible and that the flow path is marked as sterile. In this
sterility test method, the product is washed with liquid D, the
eluate is subjected to membrane filtration, and then transferred to
liquid thioglycolic acid medium (FTM) and soybean casein digestion
medium (SCDM). . Both media were incubated for 14 days and
microbial growth was examined daily.
4. The most robust membrane filtration
Steritest is a closed system membrane filtration sterilization test
that maximizes safety and convenience.
5. Rapid sterility testing
Winteam Rapid System is based on adenosine triphosphate (ATP)
bioluminescence for rapid sterility testing and rapid bioburden
testing. With the fast sterility test system, you can get results
in 5 days.
Official sterility test source used by the Gibraltar Institute:
USP <71> Sterility Test
According to AAMI / ANSI / ISO guidelines.
Sterility testing is an extremely important step before the release
of sterile products. False-positive, false-negative experimental
results, as well as experimental equipment failures and human error
can cause significant time and money losses to the customer and
directly affect the laboratory performance of the product. The
combination of the Ai series collection instrument and the
collection culture incubator provides a perfect solution. The test
samples of different packaging forms are safely and uniformly
transferred to the collecting culture incubator by the peristaltic
pump of the collecting instrument, so that the sterility test
results are more consistent and reliable.
Features
- 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.
- SAL 10 10-6, in line with the requirements of the 2015 Chinese
Pharmacopoeia radiation sterilization method.
- The ultrasonic welding process ensures air tightness and pressure
resistance.
- 100% passed the airtight performance test.
- Microbial microbial retention, microbial growth (sensitivity) and
sterility testing ensure reliable and reliable results of sterility
testing.
- Transparent blister packs conform to international standards.
- Transparent composite packaging to reduce packaging waste and
reflect environmental protection
- Imported medical dialysis packages from the United States can be
used to rapidly degrade ethylene oxide and reduce ethylene oxide
residues to ensure product sterility.
- Microbial microbial retention, microbial growth (sensitivity) and
sterility testing ensure reliable and reliable results of sterility
testing.
- Filter: bubble point method, bacterial retention test.
- Chewing stability test: The culture 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 |
Pharmaceutical industry: sterility inspection and microbial limit
inspection of purified water, water for injection, sterile
preparations (large infusion, small injection, powder, biological
products, blood products, ophthalmic preparations, maintenance
liquid, etc.);
Medical device industry: sterility inspection and microbial limit
inspection of purified water, water for injection, syringe,
infusion set, blood transfusion device, intravenous catheter, etc.
Product rinse sterility test
Combination product: Product rinse sterility test is only
applicable to products with hollow tubes, such as infusion and
infusion sets, which are not suitable for soaking and the fluid
channel is marked as sterile, this method is easy to operate and
requires modification of FTM media with liquid D rinse products,
The eluate was membrane filtered and placed in FTM and SCDM. This
method is usually not used.
Bulk drugs / biopharmaceuticals
Bulk drugs (API) have been sterilised according to USP 71 prior to
release to the manufacturing process.
Bulk biologics are tested for sterility according to 21 CFR 610.12,
which requires a medium (FTM) with sample test sizes listed in the
document and a capacity of not less than 10 ml.10
Interpretation of sterility test results
Technicians must be trained in growth testing methods during the
cultivation process. Growth is determined by observing a medium
that is generally transparent and transparent with respect to the
light source, and the turbid (turbid) area of the medium
indicates the growth of microorganisms. Once growth is detected,
the suspect container is tested to confirm that the turbidity
present is due to microbes, not due to decomposition of the sample;
sometimes, the sample becomes cloudy due to particle shedding or
chemical reaction with the medium. After testing, return to the
incubator for the remainder of the incubation period. Samples
turbid in the medium were transferred and displayed for four days
on the 14th day of the test.
