Surgical Suture Eto Sterilizer

Chirurgiese hechting ETO Sterilisator

Advanced Low-Temperature Solution for Synthetic & Bio-absorbable Sutures

Sterilization Method Comparison

Metode	Suitability for Sutures	Impact on Material Performance
Etileenoksied (LINE UP)	Industry Mainstream (High Penetration)	Minimal impact on tensile strength; shelf life up to 5 years.
Gamma Ray	Common Industrial Use	Risk of polymer degradation (e.g., PP, Polyester).
Steam/Boiling	Not Recommended	Significantly reduces strength; fibers may swell or embrittle.

Tensile Strength

Our deep-vacuum cycles ensure zero structural damage, maintaining the critical strength needed for healing.

EO Residue Control

Strictly compliant with national standards (≤250μg/g) through optimized pulsating aeration cycles.

Moisture Content

For PGA/PLA sutures, our dry screw pump ensures moisture ≤0.05% to prevent premature hydrolysis.

Aeration & Degassing Performance

Conventional System

48 Hours

BOCON Suture System

< 12 Hours

Key Parameters	BOCON Dry Screw	Traditional System
Ultimate Vacuum	-101.27 kPa	-97 kPa
Hydrolysis Risk	Zero (Pure Dry)	High (Moisture Risk)
Voldoening	ISO 11135 / 21 CFR Part 11	Basic Standard

Compact High-Efficiency Unit

Model: 1.5 CBM (1.5m³)

Specifically engineered for surgical suture manufacturers. Combines a small footprint with the deep-vacuum power of industrial-scale systems.

Professional FAQ

Only monofilament (Nylon, PP) or coated sutures are recommended for re-sterilization under limited resources. Multi-strand braided sutures (like silk) should never be reused as pathogens can hide in fiber gaps.

For absorbable sutures (PGA, PLA), moisture accelerates hydrolysis. Our dry screw technology ensures an ultra-dry environment to maintain the suture's integrity and strength throughout its shelf life.

While Gamma is efficient, it can degrade synthetic polymers like Polyester. ETO remains the gold standard because it provides high penetration without compromising the physical strength of the suture material.

Validated Sterilization Cycle Process

IK / OQ / PQ Validation Support

N2 Process Safety: Flammable Region Control

PREPARATION

Loading & Setup

Open the loading door, load the products. All of the doors closing. Appropriate parameters setup. Start the cycle.

STEP 01

Heating

Heating up to 52℃.

STEP 02

Keep warm

The system will keep warm for 10 mins.

STEP 03

Pre-Vacuum

Vacuum to -90kPa according to the user parameters.

STEP 04

Leak testing

Duration is 13 mins.

STEP 05 (SAFETY)

Air to N2 replacement

Replacing the chamber air to N2 gas, 1-2 times.

STEP 06

Humidifying the chamber

The products will be humidified to up to 55%RH.

STEP 07

Humidity dwelling

Duration is 30 mins.

STEP 08

N2 blanket to the chamber

EO pipe washing and preparing the chamber for the EO gas injection.

STEP 09 (INJECTION)

EO injection to the chamber

The EO gas is injected into the chamber to reach pressure of 25 kPa.

STEP 10

N2 Cover

The process is to wash EO pipe and let all the EO go into the chamber.

STEP 11

EO Dwelling

It will hold on 2 hours and 10 mins.

STEP 12

EO removal

Removing almost all the EO gas out under vacuum.

STEP 13 (SAFETY)

N2 washing

Injection of N2 gas into the chamber to replace all the EO gas for safety.

STEP 14

Air washing

Washing the products with air, after the air washing process the EO residue becomes very low.

STEP 15

Aeration

This process has the same function with Aeration room, ensuring the EO residue much less.

COMPLETE

Cycle Finished

Pressure goes up to -3.0 kPa~3.0 kPa. Open the unloading door and unload products. Print out history data.

5-YEAR WARRANTY FOR ENTIRE MACHINE

Your Trusted Global ETO Sterilizer Vennoot

As a leading industrial ETO sterilizer manufacturer, BOCON provides more than just equipment. We deliver a turnkey ETO sterilization system backed by 15+ years of engineering excellence. From initial design and IQ/OQ/PQ validation to lifelong technical support, we ensure your medical device sterilization process is safe, compliant, and efficient.

Global Installation

On-site setup and commissioning by expert engineers.

Full Validation

Comprehensive IQ/OQ/PQ documentation and support.

24/7 Ondersteuning

Remote diagnostics and rapid spare parts delivery.

Ready to Deploy a Reliable
Industrie ETO Sterilisator System?

Whether you need a laboratory-scale unit or a large-scale industrial ETO sterilization system, our engineers are ready to provide a customized technical proposal.

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