Reverse Osmosis / De-Ionized Water (RO/DI) Calibration

Reverse osmosis / de-ionized water systems (RO/DI) are used to generate high-quality water for pharmaceutical applications that includes drug manufacturing, lab testing, and equipment cleaning, To maintain the reliability of these systems regular calibration is required to not only maintain compliance with federal regulations, but to make sure their are no deviations in the manufacturing process which could lead to product defects or recalls. GL Technologies works with biopharmaceutical clients throughout California for all their equipment calibration and certification requirements. As an ISO 17025 certified company, our team of professionals has the knowledge and skills to keep your equipment accurate.

To speak with the experts about your RO/DI calibration needs, please fill out our online form or give us a call!

858-202-1408

Why Calibration Matters

Maintaining the consistency of RO/DI water quality is important, and proper calibration of the equipment keeps the integrity of the system in tact. In general, RO/DI systems are designed to remove impurities in the water such as dissolved salts, minerals, or any other organic compounds. Depending on the usage and age of the equipment, these systems can decline. Calibration works to identify and deviations from the needed water quality standards and provides the opportunity for corrective actions to fix any issues that may be found. This process keeps biopharmaceutical company's research and manufacturing processes both compliant with federal regulations and SOP's in line.

Calibration Process

The calibration process for RO/DI water systems involves several key steps:

Sampling

Sampling starts by selecting representative points within the water distribution system and collecting samples in sterile containers. The samples are put through testing of the measuring parameters including conductivity, pH, and total dissolved solids. Careful attention needs to be paid to labeling and recording of each sample to make sure it meets the SOPs (standard operating procedures) of the calibration process.

Analytical Testing

Analytical testing is conducted to provide insights into the system's overall performance and the presence of any contaminants or deviations from the required standards. This procedure involves calibrating the instruments to analyze water samples with RO/DI water which has been purified, eliminating impurities. With the calibration of the analytical equipment using RO/DI water, you will be able to establish a baseline measurement for the detection and quantification of contaminants in subsequent samples. This process provides researchers the ability to conduct reliable analysis which are a fundamental need in the bio-pharmaceutical industry.

Calibration Procedure

The calibration process starts by checking the accuracy of the conductivity meter using a certified calibration solution and adjusting as needed. Subsequently, the pH metr is calibrated using standard buffer solutions to establish pH measurements. By properly preparing for the RO/DI calibration process, the accuracy and overall performance of the system can be validated, making sure there is optimal water quality for your research applications.

Documentation

When it comes to the documentation of the calibration process, this is an extremely important aspect because it provides a complete report of all the necessary steps, measurements, and adjustments involved in maintaing the RO/DI system. It should include detailed procedures for calibrating and validating key parameters including pressure, temperature, and flow rates. Proper documentation also serves as a reference for troubleshooting and identifying any deviations in the system and provide for a quick solution. The documentation supports the smooth operation of research applications for laboratories and pharmaceutical manufacturing.

Benefits of RO/DI Water Calibration

Proper calibration of RO/DI water systems offers several benefits to the biopharmaceutical industry:

Consistent Product Quality

One of the top benefits for RO/DI water calibration is consistent product quality. Through the calibration process, the water used in pharmaceutical applications can be purified to the highest purification standards. Both reverse osmosis and deionization work hand in hand to remove contaminants and minerals from water which results in a pure water source. The water purity level validates that products manufactured with RO/DI water are consistent in quality and free from substances that could compromise the performance or safety. Biopharmaceuticals can uphold strict control quality measures in their processes.

Regulatory Compliance

Maintaing regulatory compliance is important for biopharmaceutical manufacturing and research, and by calibrating RO/DI water systems, company's can maintain compliance with regulations such as cGMP (curren good manufacturing practices), or other agencies like the FDA. With calibrated RO/DI water systems, organizations can demonstrate their commitment to quality, safety, and compliance.

Improved Processes

Proper calibration improves operational efficiency through minimized downtime that can be caused by inaccurate readings or equipment failure. With improved processes through water calibration results in reduced resource consumption of chemicals, energy, and water which leds to cost savings and overall environmental sustainability.

GL Technologies Calibration Solutions

As a team of experts specializing in biopharmaceutical equipment calibration and certification, GL Technologies works with biopharmaceutical companies throughout California for all their certification, validation, and calibration needs. We help keep our clients compliant with regulatory standards and to maintain the highest industry research practices through both laboratories and manufacturing processes.

To speak with the experts about your RO/DI calibration needs, please fill out our online form or give us a call!

858-202-1408