PHARMACEUTICAL

Automatic Glove Leak Testing System (AGLTS) for isolators and RABs

Leading the way in creating sophisticated integrity testing systems for gloves used in the pharmaceutical sector, AGLTS adheres to ISO 14644-7 Annex E5 international standards and GMP compliance. AGL is recognized as the most advanced glove system for isolators and RABs in the pharmaceutical industry. It offers rapid and dependable performance while remaining highly user-friendly. Its control cycles are fully automatic, and the unit operates wirelessly.

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Sterility Testing Isolator Systems(ST-IS)

Leader in producing cGMP Class A/ISO 5 modular isolators, specifically crafted for quality control activities in the pharmaceutical industry, with a focus on sterility testing. Every aspect is meticulously designed to achieve the highest level of asepsis for the working area. By integrating all necessary processing equipment within the isolation system during the design phase, we create an optimal work for effectively conducting all QA processes in the pharmaceutical sector.

Cell Culture Isolator Systems(CC-IS)

The latest product line features the ATMP systems, leveraging extensive in aseptic processes to enter this rapidly growing industry. This has led to the development of a cGMP Class A/ISO 5 Cell Culture Isol, specifically tailored for cell and gene autologous therapy activities, including the activation and transduction processes of non-infectious viruses and viral vectors that may become infectious or overexpressed.

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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.

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

Thermal Mapping Services

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

NCG

Dryness Test

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.

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

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

Mean Kinetic Temperature (MKT), if required.

Detailed reports listing all logs.

Clear graphical data for each sensor.

Calibration certificates (UKAS or UKAS Traceable).

Loaded and empty distribution studies.

Loaded and empty penetration studies.

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

Clear sensor location diagrams.

Non-conformance reports.

Service & Equipment

We offer specialized pharmaceutical services alongside advanced production and packaging equipment. Our services include refurbishment, validation, and quality assurance for sterile environments, while our equipment supports sterilization, filling, packaging, inspection, and track-and-trace. This provides end-to-end support that improves efficiency, ensures quality, and meets industry demands.

Food Sterilizers & Retorts

Designed for efficient batch and continuous sterilization processes used in food production lines.

Liquid Filling Systems

Engineered for precise liquid dosing and hygienic filling operations across pharmaceutical and beverage sectors.

Horizontal form‑fill‑seal packaging

Specializing in Horizontal Form-Fill-Seal (HFFS) machinery, they are known for their pouch and sachet packaging technology used in food, cosmetics, and pharmaceuticals.

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Softgel Machinery

Specializes in rotary die softgel encapsulation, offering complete turnkey production lines for pharmaceutical, nutraceutical, and cosmetic industries.

Autoclaves & Sterilizers

RSA PREMIUM is a cGMP 3-in-1 sterilizer that uses clean saturated steam for solids, air/steam mixtures for small liquids, and overheated water for large containers.

Leak Testing Machines

Non-destructive, deterministic Container Closure Integrity Testing (CCIT) systems for pharmaceuticals, food, and aerosol packaging use the Vacuum Decay Method (VDM) to identify micro-leaks and ensure compliance with USP 1207 and EU Annex regulations.

Sachet & Stick Pack Systems

High-speed vertical packaging machines engineered to create-friendly stick packs and four-side sealed sachets.

Wrapping Packaging

Focuses on complete turn-key solutions for flow wrapping and cartoning systems.

Case Packing

Advanced packers for cases and trays that manage wrap-around configurations, trays, and tray-withid combinations.

Track & Trace Inspection Systems

Offers comprehensive serialization, aggregation, and tracking solutions the modular DIAMIND platform, providing hardware and software to assign unique digital identities, track supply chains, fight counterfeiting, and ensure compliance in the pharmaceutical, food, beverage, and cosmetic sectors.

KAYE

The Kaye product range is relied upon by the world’s leading pharmaceutical and biotechnology companies to validate and monitor critical assets and processes like sterilization as required by governing regulatory bodies. Kaye products are designed to meet the most demanding requirements for process improvement, thermal validation and environmental monitoring.

Kaye Validator AVS

The Kaye Validator AVS is an advanced validation system designed for temperature mapping and thermal validation. It integrates precise sensor measurements, GxP compliance for calibration and traceability, and features improved hardware, user-friendly data handling, and an intuitive software interface. This makes it highly effective for applications such as autoclave temperature mapping, ensuring both ease of use and regulatory compliance.

Autoclave Temperature Mapping

Kaye Validator 2000

Kaye ValProbe RT (Real Time-RF) System

Kaye ValProbe® RT (Real-Time) is a wireless thermal validation system designed around the specific thermal validation and regulatory needs of the Pharmaceutical and Biotech industries. As the reliability, repeatability and accuracy of real-time wireless technology has continued to evolve, Kaye has utilized the latest advances in RF and battery technology to design the most advanced wireless thermal validation system on the market.

Base Station

Flexible Real-Time Logger

Bendable Temperature Logger

Rigid Temperature Logger

Freeze Dryer Temperature Logger

Pressure Temperature Logger

Humidity Temperature Logger

Kaye ValProbe Standard Loggers Standard

The ValProbe® system's wireless probe design eliminates the need for hard-wired sensors, simplifying access to hostile, remote or hard to reach environments. The ValProbe system is ideally suited for applications where high measurement accuracy and regulatory compliance are priorities:

Pharmaceutical Processing
Medical Device Sterilization
Food Processing
Environmental Monitoring

Temperature Logger

Cyro Logger

Freeze Dryer Logger

Pressure/Temperature Logger

Humidity/Temperature Logger

Kaye RF ValProbe Loggers

The Kaye RF ValProbe II Wireless Data Logger integrates breakthrough RF Mesh technology with enhanced technology for Thermal Validation and Temperature Monitoring. The operating range of the loggers of -40°C to +60°C and temperature sensor range of -200°C to +200°C make them ideal for real-time RF validation and monitoring of environmental chambers, warehouses, freezers, refrigerators, and steam-in-place (SIP) applications.

Kaye RF ValProbe II Loggers

Kaye RF ValProbe Loggers

VUZIX

Vuzix, always innovating and adapting to create the best product for consumers and enterprises using their optics and Waveguide technologies. Smart glasses can be used in warehousing, remote support, manufacturing, navigation, entertainment, gaming as well as learning, and many more.

The possibilities for this technology are constantly growing and evolving with the changing demands of industry.

All M-SERIES Smart glasses are mountable on accessories such as safety helmets.
All M-Series Smart glasses support both the left and right eye.

The M4000 uses market-leading M400 as a foundation. Having added the revolutionary Waveguide optics to the platform, it enables see-through displays for a more natural viewing state paired with the M-series ergonomic design.

The M4000 is built around the latest technology available and uses the purpose-built Snapdragon XR1 processor by Qualcomm for highest level performance available to smart glasses.

Vuzix M4000

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VSIGHT

Workflow

By scanning the QR code, you can quickly initiate the relevant workflow and follow precise step-by-step instructions tailored to your responses, ensuring tasks are accomplished accurately and effortlessly. Once tasks are completed, you can submit them for approval and obtain a digital signature.

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