AELAB Sterile Test Kits for Reliable Pharmaceutical Quality Control

Q: What sterilization method is used for these kits?

All kits undergo specialized ethylene oxide sterilization with minimal residuals, ensuring safety and compliance.

Q: Can these kits be used for both antibiotics and non-antibiotics?

Yes, dedicated models exist for both, ensuring compatibility with different drug formulations.

Q: How do the kits prevent leakage during testing?

Ultrasonic welding technology ensures smooth, durable, and leakproof connections.

Q: Are membranes customizable?

Yes, 0.22μm and 0.45μm pore sizes are standard, but other options can be customized upon request.

The AELAB Sterile Test Kits are meticulously engineered through over 50 strict inspection processes to ensure accuracy and safety in sterility testing. Manufactured under ISO9001 quality standards, each kit undergoes 100% completeness examination to guarantee reliability and traceability. With 34 specialized models tailored to different sample types and packaging formats, these kits are the trusted choice for pharmaceutical sterility inspection.

Modles : Sterile Test Kits

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🔬 How It Works?

The sterile test kits employ a membrane filtration method, where test articles pass through a microporous filter (0.22μm or 0.45μm) that captures microorganisms. Depending on the sample type—ampoule, vial, LVP, pre-filled syringe, or emulsion—the kit uses specialized adapters, tubing, and membranes to ensure complete, contamination-free filtration and accurate sterility results.

💡 Advantages

ISO9001-certified manufacturing with full traceability
Leakproof ultrasonic welding for maximum reliability
Low EO residuals ensuring product safety
Strong chemical and mechanical resistance in pump tubing
Wide variety of models tailored to different pharmaceutical packaging types
Transparent blister packs for easy handling and sterility assurance

🔍 Recommended Models by Use Case

LVP in Bottle or Soft Pouch: PY220, KSF220, SDY220 series
Liquid in Ampoule: APY220 / KAPY220 (antibiotics/non-antibiotics)
Powder in Vial: DGB220 / KDGB220 for dissolution and filtration
Insoluble Powder in Vial: NKF220 series with three-needle adapter
Pre-Filled Syringe: PFS2 / PFS2D for closed-system transfer
Viscous Liquids & Biological Products: CN220, DCN220 series
Medical Instruments with Catheter: YLQ220 series
Small Volume Parenteral (<5mL): DGB203 / KDGB203D

🧪 Ideal For

Pharmaceutical sterility testing labs
Biotechnology and biological product QC
Injectable formulation analysis (ampoules, vials, pre-filled syringes)
Medical device sterility validation (catheters, infusion sets, dialysis tubing)
Regulatory compliance testing under GMP standards

Performance:

Specialized ethylene oxide sterilization
Transparent blister box packaging, compliance with international standards
Ultrasonic welding process, smooth and secure weld, optimal leak proofness
High FL flexible pump tube made by special composite, durable tension, wear- and pressure-resistant, filtration of maximum test articles completed smoothly
Medical dialysis packaging imported from US adopted, sterility of products ensured, quick decomposing of ethylene oxide, less ethylene oxide residual
Membrane pore size：0.45μm,0.22μm (Can be customized)

Specifications :

Applications		Single Layer Pouch package	Blister Package	Double Layer Pouch Package (E-beam Sterilized)	Feature
LVP in Bottle	W/O Antibiotics	PY220	B-PY220	PY220D	Side hole and double core needle
LVP in Bottle	With Antibiotics	KSF220	B-KSF220	KSF220D	Longer tube and can be used together with HTY-K shaker
Liquid in Ampoule	W/O Antibiotics	APY220	B-APY220	APY220D	Longer needle which could transfer the samples quickly
Liquid in Ampoule	With Antibiotics	KAPY220	B-KAPY220	KAPY220D	Longer needle which could transfer the samples quickly
Powder in Vial	W/O Antibiotics	DGB220	B-DGB220	DGB220D	Double needle adapter which could realize dissolution, filtration and flush at the same time
Powder in Vial	With Antibiotics	KDGB220	B-KDGB220	KDGB220D
Insoluble Powder in Vial, With Antibiotics		NKF220	B-NKF220	NKF220D	Three needle adapter which could realize dissolution, dilution filtration and flush at the same time
LVP in Soft Pouch		SDY220	--	SDY220D	Larger diameter side hole needle
Medical Instrument with Catheter (Infusion Set, Transfusion, Dialysis Tubing and Intravenous Tubing etc.)		YLQ220	--	YLQ220D	Special connection to connect the medical instruments
Soluble Powder in Ampoule		DGA220	--	DGA220D	Single controllable needle design which could dilute and filtrate at same time
Viscous Liquid (biological products)		CN220	--	CN2220D	Reinforced filtration membrane
Lyophilized Powder for Injection (biological products)		DCN220	--	DCN220D	Increase dissolution tube, reinforced filtration membrane.
Pre-filled syringe		PFS2	--	PFS2D	Can be used with a variety of pre-filled syringes to transfer. Closed system, effectively reduce the risk of contamination
Emulsion or hard filtrating aqueous samples		--	EVS2	--	High flow rate filtration membrane with protective padding
Small Volume Parenteral in vial less than 5mL	W/O Antibiotics	DGB203	--	DGB203D	Needle-inside-Needle design

Applications		Single Layer Pouch package	Blister Package	Double Layer Pouch Package (E-beam Sterilized)	Feature
LVP in Bottle	W/O Antibiotics	PY220	B-PY220	PY220D	Side hole and double core needle
LVP in Bottle	With Antibiotics	KSF220	B-KSF220	KSF220D	Longer tube and can be used together with HTY-K shaker
Liquid in Ampoule	W/O Antibiotics	APY220	B-APY220	APY220D	Longer needle which could transfer the samples quickly
Liquid in Ampoule	With Antibiotics	KAPY220	B-KAPY220	KAPY220D	Longer needle which could transfer the samples quickly
Powder in Vial	W/O Antibiotics	DGB220	B-DGB220	DGB220D	Double needle adapter which could realize dissolution, filtration and flush at the same time
Powder in Vial	With Antibiotics	KDGB220	B-KDGB220	KDGB220D
Insoluble Powder in Vial, With Antibiotics		NKF220	B-NKF220	NKF220D	Three needle adapter which could realize dissolution, dilution filtration and flush at the same time
LVP in Soft Pouch		SDY220	--	SDY220D	Larger diameter side hole needle
Medical Instrument with Catheter (Infusion Set, Transfusion, Dialysis Tubing and Intravenous Tubing etc.)		YLQ220	--	YLQ220D	Special connection to connect the medical instruments
Soluble Powder in Ampoule		DGA220	--	DGA220D	Single controllable needle design which could dilute and filtrate at same time
Viscous Liquid (biological products)		CN220	--	CN2220D	Reinforced filtration membrane
Lyophilized Powder for Injection (biological products)		DCN220	--	DCN220D	Increase dissolution tube, reinforced filtration membrane.
Pre-filled syringe		PFS2	--	PFS2D	Can be used with a variety of pre-filled syringes to transfer. Closed system, effectively reduce the risk of contamination
Emulsion or hard filtrating aqueous samples		--	EVS2	--	High flow rate filtration membrane with protective padding
Small Volume Parenteral in vial less than 5mL	W/O Antibiotics	DGB203	--	DGB203D	Needle-inside-Needle design