Full Range of Tubing Materials
ValPlus™ Tubing Validation Certification

ValPlus™

Confidence Through Validation

ValPlus annual testing program

What is ValPlus™?

ValPlus™ is a certificate of ultra-cleanliness for our tubing. It's a validated product that proves our tubing is rigorously tested and consistently meets the highest standards for cleanliness right out of the box.

As clarification, we do not wash or dry the tubes, we simply certify the cleanliness of the tubing.

What are the benefits of ValPlus™?
  • No pre-rinsing needed! Our ValPlus™ certified tubing is meticulously manufactured to be pristine from the start, making any pre-use washing by us or you completely unnecessary. This means you don't have to rinse and dry it with expensive "Water for Injection" (WFI) before you use it. This saves a significant amount of time, labor, water, and energy in both our and your own facility.
  • Reduced risk: ValPlus™ gives you extra confidence that the tubing won't introduce unwanted particles, bacteria, or endotoxins into your sensitive pharmaceutical products. We've done the testing for you, so you have confidence in the inherent cleanliness of our products.
  • Faster time to market and cost savings: By eliminating your need for pre-rinsing and reducing your own validation efforts, ValPlus™ can help you get your products to market faster and significantly cut down on operational costs.
  • Sustainability: Since our tubing arrives ready for use, neither our manufacturing process nor your operations require WFI for rinsing. This directly contributes to significant water and energy conservation, reducing environmental impact.
How does ValPlus™ work?

ValPlus™ isn't about us flushing and drying your tubing before shipping. Our manufacturing process is designed to produce tubing that is inherently clean. ValPlus™ is a validated program where we regularly test our tubing for:

  • Particulates: We ensure that fluid extracts from tubing meet USP <788>, Particulate Matter in Injections criteria.
  • Bacterial endotoxin: Tubing is tested in accordance with USP <85>, and is below specified product limits for endotoxins, which are substances released by certain bacteria that can be fever inducing.
  • Bacterial Bioburden (Aerobic and Fungal): We verify that the tubing has a very low count of microorganisms.

 

These tests are performed annually on samples from our production batches at our ISO 17025 accredited Analytical Services and Quality Control Test laboratory. We then provide you with the certification that verifies these strict standards are consistently met.

Step 1

We perform a comprehensive ValPlus™ tubing validation to demonstrate our confidence that the tubing meets stringent cleanliness standards for particulates, bacterial endotoxins, and bioburden.

Step 2

We produce ValPlus™ tubing and perform testing annually at our own ISO 17025 accredited Analytical Services and Quality Control Test laboratory.

Step 3

You receive the tubing with a Certificate of Conformance, and no lot release testing is required. 

Industry Requirements:
sub-visible particulates

USP <788> for Sub-visible Particulates

endotoxin

USP <85> and <161> for Endotoxins

bioburden

ISO 11737 for Bioburden

ValPlus™ certification is currently available for select sizes and formulations of the following industry leading brands: 

C-Flex® Biopharmaceutical Tubing

Learn more about C-Flex® Biopharmaceutical Tubing formulations

PharmaFluor® FEP Tubing

Learn more about PharmaFluor® FEP Tubing formulations

Sani-Tech® SPT-60L Silicone Tubing

Learn more about Sani-Tech® SPT-60L Silicone Tubing formulations

Sani-Tech® STHT®-80 Silicone Tubing

Learn more about Sani-Tech® STHT®-80 Silicone Tubing formulations

Sani-Tech® STHT®-C & Sani-Tech® STHT®-65 Silicone Tubing

Sani-Tech® STHT®-R Silicone Hose

Learn more about Sani-Tech® STHT®-R Silicone Hose formulations

New Webinar: ValPlus™, Enhance Your Tubing Validation and Sustainability Efforts

Available to watch on demand now! Don’t miss this opportunity to enhance your production processes with ValPlus™. Watch this 30 minute webinar on demand, inclusive of Q&A with our speakers. 

C-Flex® tubing formulation

Saint-Gobain's ValPlus­™ reduces water usage for the biopharmaceutical industry. 

Sustainability Benefits

  • Reduce Water for Injection (WFI) consumption
  • Reduce energy required to dry the tubes
  • Save millions of liters of water

The documented cleanliness of ValPlus™ eliminates the need for you to rinse and cleanse the inner part of the tube. Our customers are reducing their usage of WFI consumption by up to several million liters and the energy reduction required to dry the tubes.

Water Stewardship
Essential Resource

Water is a limited resource in biopharmaceutical manufacturing with no alternatives as a "raw material."

Stringent Quality Requirements

The industry relies heavily on a consistent supply of high-quality water.

Water Consumption

The combined water consumption of 10 major pharmaceutical companies equates to more than 56 billion liters of water per year.

The ValPlus™ Solution - Validation, Sustainability, Confidence

New White Paper: Mitigate Risk, Lower Overall Cost, and Enhance Sustainability Efforts with Saint-Gobain ValPlus™ Certification

C-Flex® tubing formulation

Saint-Gobain's ValPlus­™ reduces water usage for the biopharmaceutical industry. 

Reduce Validation Costs and Increase Speed to Market with ValPlus™
Video: ValPlus™ - Enhanced Tubing Validation

ValPlus™ is an enhanced validation package offered on Saint-Gobain Life Sciences tubing which provides certification that bioburden, endotoxin and particulate criteria are met. This may allow for reduced validation at the bioprocessing facility, which increases speed to market and reduces validation costs.