Reliable closed sterile canister ISO9001 AS base for Pharmaceutical
factory
How much material do I need for testing?
The amount of material and the minimum number of samples to test
depends on the number and size of vials produced per production
lot. The IHC describes the minimum number of test items to check
the sterility of the entire batch. WINTEAM can advise on the number
of samples required for batch release.
Bioburden test
The need for sterility between biopharmaceuticals varies. Certain
products, such as those intended for intravenous injection, must be
proven as sterile, but other products may require microbiological
restrictions. This is a limit to the microorganisms that can be
contained in the final product, so the risk to the consumer is very
low, but reasonable for manufacturing. In these cases, bioburden
testing should be used instead of infertility testing. The
bioburden test assesses the microbial content of a product. In this
test, samples were used to inoculate agar plates. Incubate the
plate and count the number of microbial colonies. This can be used
to determine the total number of microorganisms present in the
product and can be compared to the tolerance limits specified in
regulatory guidelines.
Characteristics of Sterility Test Canister
- Assembled clamps for pipelines are more convenient to use;
- Double-layer aseptic packaging facilitates the transfer in the
clean room and reduces the pollution during the transfer process;
- Transparent blister packs conform to international standards.
- Transparent composite packaging to reduce packaging waste and
reflect environmental protection
- Produces in 10,000 grade level clean room
- Composite membrane packaging technology, great breathability and
bacteria resistance.
- Ultrasonic welding technology, ensures leakproofness and withstands
pressure.
Sterility testing is an extremely important step in the release of
sterile products. False positives, false negative test results, and
laboratory equipment failures and human error will bring a lot of
time and money to the customer and directly affect the final
release of the product. The collection of YT series of bacterial
collection equipment and sterile culture equipment provides the
perfect solution. The test sample pump in different packaging forms
is safely and evenly transferred to the collection incubator by the
peristaltic collection instrument pump, so that the sterility test
result is more consistent and reliable.
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 |
Sterility examination should be carried out under aseptic
conditions. The test environment must meet the requirements of
sterility inspection. The whole process should be strictly followed
by aseptic operation to prevent microbial contamination. Measures
to prevent contamination should not affect the detection of
microorganisms in the test sample. The unidirectional flow air
zone, work surface and environment shall be regularly checked for
cleanliness according to the current national standards for test
methods for suspended particles, planktonic bacteria and settled
bacteria in the clean room (district) of the pharmaceutical
industry. The isolation system shall be verified periodically
according to the relevant requirements, and the cleanliness of its
internal environment shall comply with the requirements of
sterility inspection. Daily testing also requires monitoring of the
test environment.
USP describes three general methods for sterility testing: 1)
membrane filtration, 2) direct transfer (product immersion) and 3)
product rinsing.
Membrane filtration sterility test
Membrane filtration sterility testing is the method of choice for
drugs, not the choice of medical devices; FDA may question the
principle of using membrane filtration testing rather than direct
device transfer testing. The test is for instruments containing
preservatives and having bacteriostatic and/or fungal static
effects under direct transfer methods. The concept of membrane
filtration is that the microorganisms will accumulate on the
surface of a filter having a pore size of 0.45 microns. The test
medium was liquid thioglycolic acid medium (FTM) and soy casein
digestion medium (SCDM), which was selected according to its
ability to support anaerobic and aerobic microbial growth. The
incubation time is 14 days, because a lot of operations are
required, so a large number of aerobic bacteria and fungi (ie yeast
and mold) are required. For sterility testing of membrane-filtered
medical devices, the possibility of laboratory contamination is
high, so in open systems, sterility may be higher when using this
method; for drugs and small devices or combination products, A
closed system is recommended. Closed using a closed system. In
closed systems, the incidence of external contamination is low.
