Pharmaceutical manufacturing facilities must ensure strict purity and contamination control under various international standards such as the American Society of Mechanical Engineers (ASME) and the American Welding Society (AWS), as well as applicable local regulations. Bacterial or foreign particle contamination of production line equipment can cause serious health problems among 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 (IVD) using boroscopes or videoscopes allows direct monitoring of the condition of processing equipment.
Videoscope insertion tubes can have an internal diameter of up to 4 mm (0.16 inches) and a length of up to 30 metres (98 feet). These tools are thus optimized to control hard-to-reach areas inside pipes, tubes, tanks and treatment tanks. 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 microorganisms tend to proliferate.
Four ways videoscopes can improve preventive maintenance procedures at drug production plants
The IVD is a practical contamination prevention tool designed to help drug manufacturers maintain the purity of their production lines to meet the requirements of good manufacturing practices (GMP). Here are four ways in which these facilities can incorporate a boroscope or videoscope into their proactive maintenance procedures:
1. Validation of the conformity of new processing equipment
Prior to the initial commissioning of new or replacement equipment, drug production facilities may conduct a reference video inspection to verify compliance with standards and regulations of welds at pipe elbows, fittings, seals and tanks. The color of the thermally affected areas (HAZ) and the porosity of the surface testify in particular to the quality of the welds. A videoscope with a high-quality image processor can adjust the intensity and color representation so that the images reflect the actual state of the welds.
Criteria for the acceptability of discoloration of welds and thermally affected areas (extract)
Reproduction of the ASME BPE-2016 standard, courtesy of the American Society of Mechanical Engineers. All rights reserved
2. Monitoring of areas suitable for the accumulation of residues
Between two changes in production batches, pharmaceutical plants must thoroughly clean and inspect processing equipment. Videoscopes allow quality assurance inspectors to check the main points of contact in order to detect any accumulation of residues or corrosion, and to monitor areas of potential proliferation of microorganisms.
3. Corrosion control of metal walls of pipes and tanks
During periodic maintenance procedures of facilities, the IVD can be used to control and monitor any possible deterioration of treatment equipment (e.g. corrosion or erosion).
4. Recording of inspection images in accordance with good manufacturing practices
After each visual inspection, an inspection report is required for verification and validation purposes. All video inspection images or videos may be recorded as evidence. The software capabilities of boroscope or videoscope systems have a direct impact on the efficiency of the reporting process. Well-designed inspection software streamlines the process.
Advantages of IPLEX™ videoscopes in the context of inspection of pharmaceutical plants
Our IPLEX™ videoscopes offer quality assurance and quality control inspectors many features that simplify the verification of processing equipment 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 the visibility of the thermally affected area (HAZ) at the weld level
Interchangeable light sources (white and ultra-violet options)
InHelp inspection assistance software™ for efficient image data management
Portable and ergonomic design facilitating the inspection of tight spaces
User-friendly interface that simplifies the use
Upgrading stereo measurement functions for quantitative defect evaluation
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