Water for Injections (WFI) Calibration

Water plays an important role in the biopharmaceutical industry, its used in a variety of manufacturing processes including formulation, cleaning, and preparation of injectable products. Water for injection, aka WFI, is purified water that meets the strict regulation standards that are required for pharmaceutical products and standards. GL Technologies works with biopharmaceutical organizations throughout California for their equipment calibration and certification needs. As an ISO 17025 company, we keep our clients compliant with regulation requirements set forth by governing bodies such as the FDA.

To speak with the experts about your water for injection needs, please fill out our online form or give us a call!

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Why is WFI Calibration Important?

In research laboratories, calibration of the equipment involves the verification and adjustment of the equipment in the lab to preserve accuracy in the testing. With WFI calibration, the goal is to make sure the quality of the water used in pharmaceutical manufacturing is pure and meets regulatory standards. Here are some reasons why companies turn to GL Technologies for equipment calibration, including water for injectables.

Compliance with Regulatory Standards

The calibration of equipment in a laboratory is a requirement to maintain compliance, including WFI systems. With regular calibration of the systems and equipment used in research and manufacturing will demonstrate to these regulatory bodies that the water purification system being used meets quality control practices.

Accurate Measurements

WFI systems have a variety of components involved in the system including filters, heat exchangers, and distribution systems that work together to maintain the needed water quality. WFI calibration makes sure that required parameters such as temperature, pressure, and flow rate are controlled. With regular calibration, any deviations can be found quickly, preventing product quality issues.

Reproducibility

Calibration works to establish a reference point for measuring how the WFI systems are performing. The testing validates that the water quality remains consistent each and every time and across various production bathces. The ability to reproduce batches consistently not only meets regulatory requirements to keep your process compliant, but also reduces product issues and potential recalls.

Calibration Process for WFI Systems

General overview of the calibration process:

Equipment Selection

GL Technologies will bring the appropriate calibration equipment, including reference standards, sensors, probes, and instruments that are able to measure the parameters of the device properly.

Establish Calibration Schedule

Biopharmaceutical companies should have an established calibration schedule set it in place based on regulatory requirements and the manufacturer's recommendations. The calibration intervals will vary with the regulations governing the industry as well as the amount of use of the instruments get. Our team will help you coordinate a calibration schedule for your company.

Perform Calibration

GL Technologies will follow standard operating procedures, or SOPs to calibrate the instruments and equipment in your lab or manufacturing facility. This will involve the adjustment of the instruments to match the reference standards and recording the calibration results.

Documentation

Always maintain documentation of calibration activities including the dates, results, and instrument identification, and those involved. These documents, or records, will serve as proof of compliance during audits and / or inspections.