Pharmaceutical manufacturing facilities are required to maintain strict purity and contamination control 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 of production line equipment can cause serious health problems for consumers and affect public confidence in the industry.
Drug manufacturers use a combination of direct and indirect quality control (QC) techniques to avoid contamination throughout the production chain. Remote visual inspection (RVI) using boroscopes or videoscopes allows direct control of process equipment status.
Videoscope insertion tubes can have an internal diameter of up to 4 mm (0.16 inch) and a length of up to 30 meters (98 feet). These tools are thus optimized for inspecting hard-to-reach areas inside pipes, tubes, tanks and process vessels. Thanks to their exceptional image quality, videoscopes can be used to look for signs of corrosion at welds, or to monitor areas where colonies of micro-organisms tend to proliferate.
Four ways videoscopes can improve preventive maintenance procedures in drug production plants
IVD is a practical contamination prevention tool designed to help drug manufacturers maintain the purity of their production lines to meet Good Manufacturing Practice (GMP) requirements. Here are four ways these facilities can incorporate a boroscope or videoscope into their proactive maintenance procedures:
1. Validation of compliance of new treatment equipment
Prior to the initial commissioning of new or replacement equipment, drug production facilities can perform a baseline videoscopic inspection to check the compliance of welds at pipe bends, fittings, joints and tanks with standards and regulations. The color of heat-affected zones (HAZs) and surface porosity are indicators of weld quality, among other things. A videoscope with a high-quality image processor can adjust the intensity and color representation so that the images reflect the actual condition of the welds.
Acceptability criteria for discoloration of welds and heat-affected zones (extract)
Reproduced from ASME BPE-2016, courtesy of the American Society of Mechanical Engineers. All rights reserved
2. Monitoring areas prone to residue build-up
Between batch changes, pharmaceutical plants need to clean and inspect processing equipment thoroughly. Videoscopes enable quality assurance inspectors to check key contact points for residue build-up or corrosion, and to monitor areas of potential micro-organism proliferation.
3. Corrosion control on metal walls of pipes and tanks
During periodic plant maintenance procedures, IVD can be used to control and monitor any deterioration in treatment equipment (corrosion or erosion, for example).
4. Recording of inspection images in accordance with good manufacturing practice
After each visual inspection, an inspection report is required for verification and validation purposes. All images or videos of videoscope inspections can be recorded as evidence. The software capabilities of boroscope or videoscope systems have a direct impact on the efficiency of the report generation process. Well-designed inspection software streamlines the process.
Benefits of IPLEX™ videoscopes for pharmaceutical plant inspection
Our IPLEX™ videoscopes offers quality assurance and quality control inspectors a wide range of features to simplify process equipment verification and record-keeping:
- Excellent image quality thanks to advanced optical components resulting from 100 years of expertise
- PulsarPic™ image processor reduces noise and refines images, ensuring high probability of detection (POD) in low-light and reflective environments
- Adjustable color saturation to improve visibility of the heat-affected zone (HAZ) at the weld seam
- Interchangeable light sources (white and ultra-violet options)
- InHelp™ inspection support software for efficient image data management
- Portable, ergonomic design facilitates inspection in confined spaces
- User-friendly interface simplifies operation
- Upgrade stereo measurement functions for quantitative fault assessment
To find out more about the benefits of the IPLEX series, visit www.olympus-ims.com/en/remote-visual-inspection/videoscope/.