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Monolab Blog

12 March 2021

About sterility test systems

First of all, what is sterility test system?

Combination of HTY sterility test pump and Steritailin® sterility test canister forms a complete enclosed membrane filtration system, also called sterility test system.

The system is used for sterility test of sterile drugs, which reduces the risk of false negative and false positive results.

Why using sterility test system?

According to regulations ( USP <71>, EU Pharmacopoeia < 2.6.1>, GMP), for sterile control of sterile products, if the test sample is filterable, membrane filtration method is the first choice to do sterility test, and the test need to be carried under sterile condition.

How to do sterility test?

Under a sterile background, like an isolator(with VHP generator), or in Class A environment with unidirectional flow under a Class B background, by using HTY sterility test pump, the test sample will be pumped into Steritailin® sterility test canister and be filtered, the potential microorganisms will be retained on the membrane. Rinse to remove the antibiotics(if needed), and pump media into the canister, then close the canister for incubation.

From sampling, filtration, media transfer to final incubation, The whole process is completed under enclosed and non-contact condition.

Who will need sterility test system?

Sterility test system is suitable for pharmaceutical companies which manufactures human sterile injections or veterinary injections, e.g. ampoules, vials, prefilled syringe, softbag, sterile medical equipments with catheter, etc.

Advantage of HTY sterility test pump:

• more than 5 models for you, suitable for different dosage forms

• providing easy and safety operation condition

• machine durable use

• validation documents available for all models

Advantage of Steritailin® sterility test canister:

• high quality raw material, better canister body and high elastic pump tube, safe for operation and durable for large test quantities

• sterilization process validated

• 100% passed air tightness test

• passed bacterial challenge test, bacterial growth promotion test and sterility test

• validation documents available