Remote visual inspection forpharmaceutical applications

Contents
Achieving and sustaining precision in pharmaceutical production
1.

Visual weld inspections during construction

2.

Inspection and validation for clean-in-place programs

3

The challenge: visual details of inspection area

3

The requirement: mitigating risks and FDA mandates

3

The potential consequences of inadequate inspections4

Solution: remote visual inspection (RVI)

4

Pharmaceutical manufacturing and RVI 

4The advantages of video borescope technology

5What to look for in a video borescope

5Summary6

2 | RVI in pharmaceutical applications

Remote visual inspection forpharmaceutical applications
Achieving and sustaining precision inpharmaceutical production
Pharmaceutical manufacturing strives for flawless precisionin the construction and operation of production machinery.
To achieve this, and to comply with the FDA (Food and DrugAdministration) regulations that mandate it, there are two
on-going quality inspection assessments that are vital forall
pharmaceutical manufacturers.
1. Visual weld inspections during construction
Quality begins in the construction process for purity piping
used in pharmaceutical production facilities. Whether offsite
at a skid manufacturer’s facility, or onsite construction ofinterconnecting pipes, the integrity of each and every weld’s
ID must be verified using a high-quality image to ensurecompliance to standards prior to use.
For companies that manufacture pharmaceutical skids,
quality documentation is required for acceptance by theend user. This means the quality and integrity of every weld
needs to be tracked and documented per skid build. Becauseof the high number of welds, there is often a dedicatedteam of inspectors for this purpose. Likewise, for high purity
pipe welding contractors engaged to construct expansions
or new facilities, weld quality must be documented for all
welds performed during construction to ensure the system
is constructed with compliance to 21 CFR §211 Subpart D, orsimilar local codes. As the number of welds inspected can bein the thousands, welding contractors often hire third parties
to efficiently and consistently perform weld inspections.
Weld inspection in high purity piping is a tall order, but criticalto ensure flow of product over welds is as-designed toprevent product buildup in undercuts or porosity. In additionto thousands of welds existing within one plant, welds arealso in obscure, difficult-to-access areas and remote visualinspection requires navigating sharp, often-90-degree
bends in the piping.
2. Inspection and validation for clean-in-place programs
Pharmaceutical Clean-In-Place programs are required
between production batches to ensure that internal surfaces
are ultra-clean without disassembly. This prevents any
product changeover cross contamination and it includes
all piping, valves, process equipment and vessels used inproduction. Visual inspections must be performed after
cleaning and before new-batch production to validate thecleanliness of product contact surfaces. The challenges
of comprehensive visual inspections mirror those of weld
inspections: internal production equipment surfaces are indifficult to access areas and encompass long, circuitous
paths while simultaneously requiring high levels of inspection
precision.

3 | RVI in pharmaceutical applications

The challenge: visual details of inspection area
When inspecting complicated equipment for weld integrity,
disassembly is not an option. Remote visual inspection
equipment is used for access. The challenge is to obtain aconsistently high quality image for inspectors to assess theweld. Typically, there are many inspectors on-site at thesame time, so ease of operation and portability are essential.
For Clean-in-Place programs, complete disassembly is
not an option either, necessitating the use of remote visualinspection equipment. In some environments, cover andcaps can be removed to enable the use of inspection
mirrors to gain additional visibility. The key challenge for
Clean-in-Place programs is productivity. Since Clean-inPlace programs require downtime between batches, thesooner the Clean-in-Place program is complete, the sooner
production is back up and running.

The requirement: mitigating risks
and FDA mandates
In pharmaceutical production, the FDA mandates thatspecific and comprehensive cleanliness protocols – mostnotably validation – are in place. Explicit specifications
are not dictated due to the wide variation in equipment,manufacturing and products. Instead, general requirementsfor pharmaceutical operations are comprised of steps
covering these areas, as detailed in FDA Title 21 Chapter I,Subchapter C, Part 211 or other similar local regulations.
• Written procedures detailing each cleaning processused for various pieces of equipment, including
variation between batches of the same product andbetween products.
• Written procedures on how cleaning processes will
be validated• Validation procedures that address who isresponsible for performing and approving the validation
study, acceptance criteria and when re-validation will
be required.
• Written validation protocols, prepared in advance ofstudies on equipment and manufacturing system, that
address issues such as sampling procedures, analyticalmethods to be used and sensitivity of those methods.
• Validation studies conducted in accordance with theprotocols, along with documentation of the results.
• Final validation report, approved by management, whichstates the cleaning process is or is not valid. Data should
support a conclusion that residues have been reduced toan “acceptable level.
The purpose of pharmaceutical Clean-In-Place programs
is to address these on-going FDA requirements. Please referto the actual FDA or other local requirements as this is asummary for awareness and is not intended to constitutethe full and accurate description of the FDA or other localrequirements.

The potential consequences ofinadequate inspections
FDA regulations are developed and continually honed basedon real-world events and strive to protect public safety.
Such is the case for the pharmaceutical manufacturing
regulations.
Substandard inspections that improperly assess cleanlinessor weld integrity can carry a steep, and often irreversible cost,
comprised of tangible, intangible and higher order costs.
Tangible costs include unplanned downtime, product losses
as well as labor and maintenance costs. In some cases, there
are legal costs or noncompliance costs.
Intangible costs include brand damage from contaminatedproducts that reach the marketplace. Higher order costs – inthe worst possible case – cause human harm or fatalities
and cannot be quantified. Higher order costs can also
include on-going brand damage that may linger long-term.
Historical events demonstrate the potential impacts of
inadequate cleanliness and validation processes. In one
example, a cholesterol-lowering drug, Cholestyramine Resin
USP, was found to contain cross contamination from theproduction of agricultural pesticides. The reuse of recoveredsolvents in the cleaning process was deemed the source ofcontamination. Second order contamination was created
when the compromised drug was sent to a packaging
facility, spawning contamination in that additional location.
Multiple batches of the product were recalled with an
FDA alert and new protocols and procedures had to beestablished to restart production.
Another historical pharmaceutical example occurred
when steroid and non-steroid products became crosscontaminated, posing a serious health risk to the public. The
root cause issue was an inadequate validation process. To
help ensure public safety, the FDA issued a product importalert until the cleanliness and validation protocols andprocedures could be brought up to adequate FDA standards.

The solution: remote visual inspection
When the stakes are high and the consequences steep or
irreversible, a purpose-built solution that delivers adequate,
compliant validation is of paramount importance. In
pharmaceutical manufacturing, validation of weld integrity
and Clean-In-Place programs is enabled by Remote Visual
Inspection (RVI).
RVI is required when a direct visual examination is notpossible and when access is insufficient to place the eye
within 24 in. (600mm) of the surface to be examined andat an angle not less than 30 degrees to the surface to beexamined. The most widely used RVI technology in purity pipe
contact surface examinations is the video borescope, which
is made up of a small diameter camera in an articulating,small diameter flexible tube connected to a digital display.
Much like a medical endoscope, which is used to probe thedepths of the human body without surgical intervention,
video borescopes are designed to discreetly yet accurately
view obscure areas inside industrial equipment.
4 | RVI in pharmaceutical applications

Video borescopes are commonly used where distance,
angle of view and limited lighting may impair direct visual
examination or where access is limited by complexity,
security or sanitary constraints or atmospheric hazards –such as in pharmaceutical manufacturing. Because of theirability to offer up-close, high definition access to difficult-toreach places without having to disassemble the equipment,
video borescopes have proven to be invaluable tools forpharmaceutical RVI in both weld inspections and Clean-InPlace program validation.
Video borescopes offer a flexible insertion tube with anarticulating camera head that enables the user to navigate
the challenging geometries of high purity piping, vessels,and valves. Even the simplest video borescope will have an
illumination source, allowing a technician to visually inspect
nooks, crannies and pathways within a dark environment.
Some video borescopes offer advanced optical tip adaptersthat allow the user to choose the proper viewing angle andfocus range based on specific application needs.
Across many industries, video borescopes have proven
their efficacy for troubleshooting as well as routine
equipment inspections of assets’ condition and health. For
pharmaceutical manufacturers, suppliers and inspection
service providers, video borescopes are the standard for
quality control and validation.

Pharmaceutical manufacturing and RVI
Video borescopes are finely crafted technologicalinstruments with a wide range of features and capabilities.
In high-value inspection cases, as in pharmaceuticalmanufacturing, the return on investment and risk mitigation
value is significant, thus the most advanced video borescopefeatures are employed.
Remote visual inspection provides quality assurance to thepharmaceutical manufacturing process that can increasesafety, reduce downtime, improve quality and validation
protocols, increase productivity and help avoid unplanned
downtime. Modern video borescopes are the leading solution
for the challenging environments and stringent regulations
present in pharmaceutical manufacturing. Video borescopes
help to achieve and maintain FDA compliance by providing
consistent and comprehensive documentation of allinspections, resulting in increased manufacturing uptime.

The advantages of video borescope technology

What to look for in a video borescopeModern video borescopes are affordable tools that improve
productivity by making it easy to ensure cleaning validationand verification, as well as provide weld quality assurance
during expansion or new construction projects. The visualability of video borescopes makes inspections more
efficient, and many provide innovative ways of documenting
inspection results so that problems are mitigated and legal
compliance is met, thus increasing the uptime of equipment
and productivity of inspectors.
Video borescopes offer distinct advantages over even thebest external examination, especially when used for industrial
maintenance that calls for sanitary internal inspection as
well as those in challenging environments. Video borescopes
can be configured with shorter or longer camera insertion
tubes, diameters for small passage access, more lighting
or greater “push-ability”, and a variety of interchangeable
optical tips to adjust the viewing angle and focus range to fit
a variety of applications.
Because video borescopes record what they see, they
are a tremendous help in inspection reporting, making it
easy to save and share information without requiring theseparate step of tallying results and preparing them in areadable format. Video borescopes enabled with Menu
Directed Inspection (MDI) software guides users through theinspection process while automatically annotating images
with asset-specific data metatags providing organizedresults. At the end of an inspection, the technician can simply
click to generate a report in Word docx and pdf formats tosave time, improve quality, and streamline the decisionmaking process. Often this information can be used toanalyze trends in equipment wear or use.
Using a camera insertion tube steered with a joystick tonavigate inside of assets can be challenging. A live, onscreen Tip Map aids inspectors in guiding the camera during
the inspection. A grid shows the tip’s direction and helps
inspectors maintain orientation for easier navigation. As
inspections sometimes need to be performed on equipmentthat has been recently shut down and may have operating
temperatures exceeding limits for even the most rugged
video borescope, it’s important that the device have atemperature warning system to alert the user and avoid
damage to the instrument. When time is critical, externalcooling sleeves can allow camera access in temperatures
greater than standard operating temperatures. Many video
borescopes will include substantial memory capacity alongwith USB and microphone ports to allow you to describe
observations at the same time they are being captured.

There are several characteristics that help define a bestin-class video borescope solution in pharmaceuticalmanufacturing:
Image quality. The combination of light output, whether it bewhite light or UV light, camera resolution, display resolution,
optics, and image processing are the five key componentsthat are required to generate a great video borescopeimage. Clean-In-Place programs rely on image quality toachieve proper validation. In order to properly evaluate theintegrity of a weld, image quality along with accurate onscreen color rendition are critical in searching for possible
defects including; overheating, undercut, sugaring, porosity,
surface cracks, and lack of weld penetration.
Cost of ownership. The nature of high purity weld inspection
and Clean-In-Place validations require that the borescope
insertion tube be constantly stressed while being pushed,
twisted, and maneuvered around corners. A video borescopewith a supple bending section, and a torsion relief section,that allows easy navigation around 90-degree bends helps
to reduce wear are tear on the device while increasing
inspection efficiency.
Ease of use. An ergonomically-designed video borescope
without a complicated set-up is best suited forpharmaceutical applications. During inspection events, there
are most likely multiple inspectors with different skill levels.
It’s important all inspectors are able to provide assessment
consistently.
Portability. Pharmaceutical production visual Inspectors
must access small spaces to ensure comprehensivevalidations. Some video borescopes are heavy or awkward,
making it difficult to access and inspect small spaces. A
portable and streamlined video borescope with a long
battery run time is ideal for hard-to-access inspection
areas and often provides improved ergonomics for longer
inspections.
Service and support. Expertise in high stakes manufacturing
environments can be a make or break decision. Adding
service, support and training to assist in video borescope
optimization helps to facilitate implementation and aid whenchallenging inspection situations emerge.

5 | RVI in pharmaceutical applications

Features. Each application has its own unique inspectionneeds. Optimizing a video borescope selection that offers
the features and capabilities to match inspection needs
is important, today and for emerging developments. For
example, some video borescopes offer Dark Boost to aid in
weld inspection. Advanced image processing tools such as
Dark Boost and High Dynamic Range (HDR) automaticallyadjust gamma and exposure in darker scenes to optimize
brightness levels providing the user the best possible image
quality without sacrificing contrast.
Measurement options. Many video borescopes offer theability to measure the size of indications with incredible
precision and accuracy. Several different measurement
technologies are available, ranging from basic comparison
measurements, traditional stereo measurement with 3D xyz
coordinate calculations at the cursors, to fully-surfaced 3D
point cloud visualizations. Not all measurement technologies
are created equally, so it is important to understandand align inspection requirements around indication
measurement and levels of accuracy and precision.

Summary

In pharmaceutical manufacturing, remote visual inspection
via video borescopes has become an industry standard.
Although video borescopes incorporate the very latest andhighly sophisticated technology, they are not difficult tomaster and can be useful in both simple and complicatedinspections. Video borescopes help save money by reducing
the time and resources formerly used to disassemble
working equipment, and they are highly effective in ensuring
quality, safety and meeting FDA regulations.
Video borescopes range from a simple utility video
borescope to those that provide the latest in measurement
technology and are designed to work in harsh operating
environments that would otherwise be impossible to access.
The environments found in pharmaceutical manufacturing
rely on video borescopes to provide high quality images
with minimal training to keep equipment in working order,
production running smoothly while concurrently increasing
safety and efficiency.

Image tagging and reporting capability. The ability to record
meta-tagged images and videos that show where, when,and by whom images were captured, and automaticallycreate an inspection report can save both time and money.
The data gathered can be invaluable in improving efficiency,
meeting compliance and ensuring quality of output. Overtime, trend analysis and creating easily searchable recordsof traceability becomes inherently easier.

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BHCS34802 (06/2020)

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