Now Available: Validation Support Services

Sterile Tube Welder Validation Services | Globe Scientific

Optional Device Services | RapidWeld II • TCD B40

Validation Support for RapidWeld II and TCD B40

Add confidence to your qualification and validation program with flexible IQ/OQ and sterile tube weld validation packages (PQ).

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Choose Your Support

Match the package to your documentation and testing needs

Select an IQ/OQ protocol when structured device qualification documentation is the priority. Add PQ validation support when sterile weld sample testing and a documented test report are also needed.

IQ/OQ Protocol

Qualification documentation

Device-specific test steps, acceptance criteria, and approval documentation for one identified system.

Best for: Customers who need controlled device qualification records.

IQ/OQ + PQ

Qualification + test support

Everything in IQ/OQ, plus sterile weld sample support, tensile and leak testing, and a documented validation test report.

Best for: Customers who need qualification documentation and laboratory test evidence.

Weld Validation (PQ)

Validation testing only

Sterile tube weld testing support without an IQ/OQ protocol, including a documented test report.

Best for: Customers who already have qualification documentation but need weld testing support.

At a Glance

Compare Service Options

Need	IQ/OQ	IQ/OQ + PQ	Weld Validation (PQ)
Structured device qualification documentation	✓	✓	—
Sterile weld sample support and laboratory testing	—	✓	✓
Documented validation test report	—	✓	✓

Package & Ordering Guide

Select Your Device Package

Include the applicable ordering code on the device quote or purchase order.

RapidWeld™ II

Sterile Tube Welder

IQ/OQ ProtocolRW2-SVC-IQOQ

Device-specific IQ/OQ protocol with organized test steps, acceptance criteria, and approval documentation for the identified RapidWeld II system.

$1,250

IQ/OQ + PQRW2-SVC-IQOQPQ

Everything in the IQ/OQ Protocol Package, plus sterile weld sample support, laboratory tensile and leak testing of returned specimens, and a documented validation test report.

$3,400

TCD B40

Sterile Tube Welder

IQ/OQ ProtocolTCD-SVC-IQOQ

Device-specific IQ/OQ protocol with organized test steps, acceptance criteria, and approval documentation for the identified TCD B40 system.

$1,250

IQ/OQ + PQTCD-SVC-IQOQPQ

Everything in the IQ/OQ Protocol Package, plus sterile weld sample support, laboratory tensile and leak testing of returned specimens, and a documented validation test report.

$3,400

Validation-Only Option

Standalone Sterile Tube Welder Validation (PQ)

For customers who need sterile tube weld testing support without IQ/OQ documentation. Includes customer-executed welding using specified tubing samples, laboratory tensile and leak testing of returned specimens, and a documented validation test report.

STW-SVC-PQ

$2,050

Pricing and scope are confirmed in the approved quotation. Sample quantities, tubing configurations, acceptance criteria, shipping, responsibilities, deliverables, and turnaround time may vary by project.

What to Expect

A Clear Path from Package Selection to Documentation

Select

Choose the package and ordering code that match the device and documentation or testing need.

Confirm Scope

The approved quotation defines sample quantities, tubing configurations, acceptance criteria, shipping, responsibilities, deliverables, turnaround time, and pricing.

Execute

IQ/OQ protocols and sample welding are customer-executed unless additional services are expressly included in the approved quotation.

Test & Report

Returned weld specimens are tensile and leak tested by Genesis BPS, followed by a documented test report.

Important Details

Qualification and Validation Information

Controlled Protocol

Each IQ/OQ protocol is issued for one identified device serial number.

Customer Execution