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PHARMA IN-HOUSE CAPABILITIES

We provide steam quality services in Singapore and Malaysia for a wide range of pharmaceutical, biotech, and healthcare companies. Our personnel are formally trained and certified to conduct steam quality testing, ensuring all tests comply with EN285 standards.

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We utilize the latest data logging technology for thermal mapping services to provide our clients with highly accurate data, with precision up to ±0.05°C. Our systems comply with 21 CFR Part 11 and are calibrated to ISO/IEC 17025:2017 standards, ensuring that our software generates clear, concise reports to expedite the review process. Our engineers, trained in our development laboratory, are available to visit your site and discuss temperature mapping protocols with you.​​

STEAM QUALITY TESTING SERVICES

The quality of steam feeding an autoclave is crucial for effective steam sterilization. Along with time, temperature, and pressure, steam quality is a critical variable that impacts the success and consistency of the sterilization process. Therefore, steam quality should be a key component of any steam sterilizer's validation.​

 

Effective sterilizing steam must meet several attributes. Steam quality refers to the measurable physical properties of steam used in sterilization, including temperature (superheat), dryness (liquid water content), and non-condensable gas content. It is important to note that steam quality does not pertain to the impurity content of the steam.

Steam Quality Test Kits

SQT Test Steam Quality Testing

SQT Test

NCG
Dryness Test Steam Quality Testing

Dryness Test

NCG

Variations from the optimal ranges of these steam properties can lead to several problems:

Wet Loads

Damaged Loads

Unsterile Loads

Failures of biological and chemical sterilization indicators 

Staining and corrosion of instruments

and containers

THERMAL MAPPING
SERVICES

Thermal mapping, or temperature mapping, involves the strategic placement of data loggers in predefined locations to measure temperature and humidity over a specific period. This process is critical when storing or transporting temperature-sensitive products such as vaccines, medications, and food, with the goal of ensuring that product temperatures remain within a specified range.

From these studies, the following insights can be obtained:

The impact of opening and closing doors on temperature

 Identification of hot and cold spots in each location

Seasonal temperature variations

Effects of electronic equipment on temperature

Temperature mapping employs wireless data loggers or thermocouples to monitor and record temperature and humidity levels at various points within environments such as freezers, ovens, or storage areas. The collected data is analyzed to identify temperature deviations or hotspots, facilitating corrective actions to maintain product quality.

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At MSV-Asia, we specialize in temperature and humidity mapping for warehouses, chambers, and temperature-controlled environments. We are equipped to work with MSV’s protocols and SOPs or adapt to your site-specific documentation. Our protocols are tailored to your processes and equipment, and we can assist in developing documentation to meet your requirements.

Our comprehensive reports, customized to your needs, include:

01

Minimum, maximum, and average temperatures for each location and overall.

02

Mean Kinetic Temperature (MKT), if required.​

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03

 

​Detailed reports listing all logs.​​​​

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04

Clear graphical data for each sensor. 

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05

Calibration certificates (UKAS or UKAS Traceable).

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06

Loaded and empty distribution studies.

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07

Loaded and empty penetration studies.

 

08

Door open, power off, and pull-down studies.

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09

Clear sensor location diagrams.

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10

Non-conformance reports.

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Do you have any inquiries?  

+65 63161053 (SG)

+606 9820277 (MY) 

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