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Keeping an Eye on Contamination in the Pharmaceutical Processing Line

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Pharmaceutical plant worker inspecting a gauge on a medicine processing tank as part of drug manufacturing process

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers) and AWS (American Welding Society) as well as applicable local regulations. Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and reduce the public’s confidence in the industry.

Drug manufacturers use a combination of indirect and direct quality control (QC) techniques to prevent contamination throughout the production line. Remote visual inspection (RVI) using borescopes or videoscopes offers a direct way to check the condition of processing equipment.

Videoscope insertion tubes can have an internal diameter as small as 4 mm (0.16 in.) and a length up to 30 meters (98 ft), making them ideal tools to access hard-to-reach locations in process pipes, tubes, tanks, and vessels. With their outstanding image quality, a videoscope can be used to check welds for signs of corrosion or monitor locations where microorganism colonies tend to grow.

4 Ways Videoscopes Can Improve Drug Plant Preventative Maintenance

RVI is a practical contamination prevention tool that can help drug manufacturers maintain product-line purity to meet good manufacturing practices (GMP) requirements. Here are four ways these facilities can incorporate a borescope or videoscope into their proactive maintenance:

  1. Validating the Compliance of New Processing Equipment

    Before initial operation of new or replacement equipment, drug production facilities can perform a baseline videoscope inspection to ensure compliance to standards and regulations for welds on pipe bends, elbows, joints, and tanks.

    Specifically, the colors of heat-affected zones (HAZ) and surface porosity indicate the welds’ quality. A videoscope with a high-quality image processor will be able to balance the illumination and color representation so the images represent the real weld condition.

    Pharmaceutical plant tanks, vessels, and pipes

    Discoloration Acceptance Criteria for Welds and Heat-Affected Zones 

    Sample #1b=Acceptable

    Sample #3=Acceptable

    Sample #5=Not acceptable

    Reprinted from ASME BPE-2016, by permission of The American Society of Mechanical Engineers. All rights reserved.

  2. Monitoring Problem Areas for Residue Buildup

    Between production batch changes, pharmaceutical plants need to thoroughly clean and inspect the processing equipment. Videoscopes enable quality assurance inspectors to check key contact locations for residue buildup or corrosion and to monitor potential locations of micro-organism growth.

    Residue inside pipe

  3. Checking Metal Walls of Pipes and Vessels for Corrosion

    During periodic plant maintenance, RVI can be used to check and monitor any deterioration of processing equipment, such as corrosion or erosion.

  4. Documenting Inspection Images to Comply with Good Manufacturing Practices

    After each visual inspection, an inspection report is required for auditing and validation. All videoscope inspection images or video can be documented as evidence. The software capabilities of borescope or videoscope systems directly impact the efficiency of the report generation process. A streamlined workflow is enabled by well-designed inspection software.

Touchscreen controlled IPLEX videoscope and insertion tube scope with flexible tip for inspecting inside processing pipes.

IPLEX™ Videoscopes’ Advantages for Pharmaceutical Plant Inspections

Our IPLEX™ videoscopes provide QA/QC inspectors in drug facilities with numerous features to ease processing equipment verifications and record keeping:

  • High image quality provided by advanced optics resulting from a century of expertise
  • PulsarPic™ image processor reduces noise and sharpens images for a high probability of detection (POD) in low-light and reflective environments
  • Adjustable color saturation to enhance visibility of the weld’s heat-affected zone (HAZ)
  • Interchangeable light sources in white and ultra-violet options
  • InHelp™ inspection assist software for efficient image data management
  • Portable and ergonomic design for inspection in restrained spaces
  • Easy-to-use user interface for simple operation
  • Stereo measurement upgrades for quantitative defect assessment

To learn more about the advantages that the IPLEX series offers, visit www.olympus-ims.com/en/remote-visual-inspection/videoscope/.

Coming soon! Learn about selecting the right videoscope solution for efficient welding inspection and report generation in an upcoming blog post.

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Sales Manager, Indirect Sales

Hafees Fraisada is a manager of indirect sales in the Middle East, Turkey, and Africa (META) region at Evident. Prior to his current role, he was a member of Evident's remote visual inspection team based in Hamburg, Germany. Hafees has more than 15 years’ experience in the medical and industrial industries, a background in science, and a master’s degree in international business administration.  

February 25, 2021
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