Knowledge Base | SaniChem Resources

Aug 202 min read

Whitepaper: Study on The Stability of Ethylene Oxide Residues Solution During Transportation

ISO 11135-7 provides guidelines for the Ethylene Oxide (EO) sterilization process and highlights the need to monitor residual Ethylene...

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Jul 241 min read

Biological Indicator Sterility Testing: A Step-by-Step Guide for Medical Device Manufacturers

Sterility of biological indicator testing is essential in the validation and monitoring of the sterilization process for medical devices,...

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Jul 161 min read

Whitepaper: Bacterial Endotoxin Kinetic Turbidimetric Interference Control Validation (Endotoxin Inhibition)

Assessing endotoxin levels in pharmaceutical drugs and medical devices is essential to prevent pyrogenic responses and septic shock in...

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Jun 261 min read

Whitepaper: Stability Study of Ethylene Oxide Solution Stored in 2°- 8°C

According to ISO 11135-7: Sterilization of healthcare products-Ethylene Oxide, when determining the suitability of Ethylene Oxide (EO)...

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Jun 52 min read

Step-by-Step Guide to Bioburden Testing in Medical Device Manufacturing

Bioburden is the population of viable microorganisms present on or in a product and/or a sterile barrier system. It is important to note...

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Sterility Validation: Bacteriostasis & Fungistasis

Feb 121 min read

Medical Device

Sterility Validation: Bacteriostasis & Fungistasis

The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile...

1,721 views0 comments

Feb 123 min read

Medical Device

Sterility Testing for Medical Device

What is Sterile? According to ISO11737-1 , an item or product is considered sterile when it is free from viable microorganisms. Viable...

872 views0 comments

Nov 5, 20232 min read

Medical Device

Sterilization Validation for Medical Devices: Navigating ISO 11135 and ISO 11137 Standards

The safety and effectiveness of medical devices are non-negotiable in the healthcare industry. Sterilization validation stands as a...

116 views0 comments

Jan 11, 20233 min read

Medical Device

What is ISO 10993 all about?

ISO 10993 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological...

161 views0 comments

Jan 11, 20233 min read

Medical Device

What is ISO 11137 All About?

ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the...

349 views0 comments

Jan 11, 20232 min read

Medical Device

What is ISO 11135 All About?

ISO 11135:2014 is an international standard that provides guidelines for the sterilization of medical devices using ethylene oxide (EtO)....

121 views0 comments

What is the Difference Between Bioburden and Endotoxin Test?

Jul 7, 20222 min read

Medical Device

What is the Difference Between Bioburden and Endotoxin Test?

What is Bioburden Testing? Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden...

4,524 views0 comments

May 26, 20223 min read

Medical Device

Bioburden Recovery Efficiency

What is Bioburden? Bioburden is the population of viable microorganisms present on or in a product. The bioburden of a product can come...

1,970 views0 comments

Dec 2, 20211 min read

Medical Device

Endotoxin Test for Medical Device

What is endotoxin? Endotoxin is a type of toxin that is produced by gram-negative bacteria. It can also be introduced into the body...

496 views0 comments

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SaniChem Resources (HQ)

No. 7 & 7A, Jalan Timur 6/1A, Mercato, 71760 Bandar Baru Enstek, Negeri Sembilan

SaniChem Laboratories (Penang Branch) (COMING SOON)

No. 6, Jalan Perniagaan Vorteks 3, Pusat Perniagaan Vorteks,14100 Simpang Ampat,Pulau Pinang, Malaysia.

Contact Us

+606-794 7606

info@sanichem.com.my

No. 7 & 7A, Jalan Timur 6/1A, Mercato, 71760 Bandar Baru Enstek,
Negeri Sembilan