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.