Boroscopy for Inspection of Piping Interior Surfaces and Weld Joints

Boroscope / Videoscope is an instrument or device which is used in the review and inspection of piping interior surface and weld joints of the pipes. It is the contemporary practice of pharmaceutical industry to use boroscope for documentation of orbital welding joints for inspection and review purposes. It is accomplished through small holes a few millimetres in diameter by means of a special Orientale probe, which transmits images directly to an LCD / LED monitor and can obtain in video as well as still images based on the specific requirements of the client.

The general objectives of Boroscopy/Videoscopy are:

• To examine and study the form of internal surface of pressure parts.
• To determine the occurrence of internal defects including corrosion, pitting or presence of foreign objects such as dust agglomerates, welding/grinding chips, crack
• To determine the amount of erosion, other extraneous problems in the locations for examination.

To take the photographs of pipe weld joints made by fusion of base material without the addition of filler and recorded in the attached external drive. It should meet the required specifications mentioned below:

• Uniformity in weld joints.
• Should have proper penetration.
• Should not have any foreign objects or pit material.

Procedure

1. The weld joints to be examined shall be made accessible for entry and movement of the fiber optic cable.

2. Synchronies the visual display with the camera tips vision for clarity.

3. Articulate the camera tip all around the seam and interrelate the joints quality.

4. The image shall be saved with the identification of the weld joints No. in appropriate folder memory card.

5. In case of rejection, the weld joint shall be marked with a specified procedure of rejection.

6. The rejection joint shall be carried for the rectification and re-offered..

7. Observation should be filled in Boroscopy Observation Sheet.

Acceptance Criteria as per BPE

Stainless steel, is one of the most preferred material for pharmaceutical applications because of its corrosion resistance and excellent durability. ( Read Alloys used in the Manufacture of Pharmaceutical Equipment). But by “stain-less” we actually mean stain-resistant. One of the main issues faced by pharmaceutical engineers, is a phenomena that often affects high-grade stainless steel equipment – “Rouging” .

Rouging of stainless steel is the result of the formation of a layer of iron oxide, hydroxide or carbonate on the surface of the stainless steel. It is a thin layer with reddish-brown, yellow or black tones, and it can indicate a de-stabilization in the naturally occurring passive layer of stain-less steel. Some forms of rouging can wipe of easily while others can stick to surfaces and, if left untreated, can cause product contamination. The occurrence of rouge is typical in water treatment systems, and pharmaceutical processing equipment. It can occur on the inner surfaces of storage vessels, buffer vessels, distillation systems, pumps, inline filters and other process equipment.

In the pharmaceutical industry rouge can be classified as

Type I : An easily wipe-able form or rouge that does not stick to surfaces and does not affect the surface of the stainless steel passivated layer. It usually originates from an external source.

Type II : Rouging that sticks to surfaces and alters the Fe/Cr ratio of the stainless steel surface. The rust colored deposits can cause underlying damage

Type III : Rouge that vitrifies into the surface, that is usually formed in high temperature steam systems. Type III rouge is black in colour and a form of magnetite.

The Causes of Rouging

The exact cause of rouging is highly debated in the pharma industry, and is not fully understood. Predicting when it will occur is difficult, as in some cases it can appear in just a couple of months, and in others it can take years before it occurs. However, it is universally agreed that the occurrence is exacerbated by high temperatures and highly corrosive environments. Rouge occurs in most pharmaceutical and biopharmaceutical facilities and often is associated purified-water systems, clean- steam systems, buffer-preparation tanks, filling lines, vial washers and steam sterilizers, according to Phamatech. Some of the known causes of rouging include:

1. Exposure to highly aggressive environments, such as steam, high pressure, high temperatures and corrosive products, and chlorides

2. Poor quality of stainless steel , poor welding, and construction, and the degree of surface roughness in the equipment.

3. Vulnerabilities and defects in the passive layer caused by inadequate passivation.

4. The presence of iron contaminants in the material that comes in contact with the system.

5. Frequently seen in hot water processes above 60 C that cause iron atoms to increasingly diffuse to the surface and to react with the oxygen present at the surface to form oxides and hydroxides

6. Improper cleaning methods, aggressive cleaning agents, and in adequate cleaning procedures can be a source of contamination

The Effects of Rouging

1. A Source of Contamination: Although rouge itself is not considered a contaminant, it creates a rough surface which can allow biological and other residue to grow and spread to the product. Rouging can accelerate the formation of bio-films that can cause contamination.

2. Reduced Life of Equipment: Serious rouging can cause “pitting” (small pits and holes in the surface) or stress cracking. This kind of deep corrosion can lead to inefficiencies in the system.

3. Can cause Blockages and Operational Problems: A build up of rouge in pipes and filters can cause blockages and mechanical failure.

4. Increases Equipment down-time : Cleaning and de-rouging procedures are time consuming and can be expensive

How to Avoid Rouge

1. Selecting the right material and surface finish for your equipment: Stainless steel composition is very important to avoid rouging. 316L is the most popular stainless steel for processing equipment as it has low carbon content. Ni and Mo content protects against chloride and are resistant to corrosion. Alloys such as C-22 offer the highest protection. Electropolishing process vessels, and piping equipment smoothens the surface and will reduce the occurrence of rouge.

2. Choosing the right equipment provider: When fabricating processing equipment, the right in-process controls for welding and installation, avoiding iron contamination, correct de-greasing and passivation procedures and familiarity with your product and ASME-BPE regulations is vital for long lasting equipment.

3. Regular inspection: Facilities should have procedures in place for periodically inspecting systems and process equipment as well as for cleaning, derouging, and passivating equipment.

4. Avoiding corrosive environments: Avoid chlorides and sulfides, high temperature steam, and if possible, lower the operating temperature, and adjust ph of products that move through the system to reduce rouging

5. Correct cleaning procedures: Systems and equipment should have scheduled maintenance and cleaning, that efficiently removes residue

De-rouging and Passivation

De-rouging is the process of removing the rouge from the surface of the equipment. Then, Passivation of stainless steel, a corrosion reaction is carried out under controlled conditions, to grow a very thin, layer of film on the surface that is protective against further corrosion.

Cleaning/De-Greasing – First, a thorough pre-cleaning must be done on the equipment. The surface is treated with an alkaline detergent that removes surface and organic residue. Any organic oily or fatty residue is also removed, known as de-greasing.

De-Rouging –

• Chemical Pickling -Next the metal oxides and hydroxides are removed using a formulated acid based solution (Nitric acid, Phosphoric acid, Citric acid, Oxalic acid).There is no single formula for the chemicals involved in de-rouging. A detailed analysis of the steel, and type of rouging in required before determining further action. An effective process will remove the deposits without damaging the underlying surface. Adherence to industry standards and environmental concerns must also be considered when selecting the right chemicals.
• Mechanical – Electropolishing, in which metal ions are removed from the surface in an electro chemical process, can be used for severe rouging. (Read Benefits of Electropolishing for Surface Finish in the Pharma and Bio-Pharma Industry)

Passivation – Chemical methods are used to regenerate the passive layer and provide increased protection. The thin chromium oxide layer on the surface of the stainless steel should be developed to avoid future corrosion.

Disposal of the Cleaning Chemicals – Proper care should be taken to neutralize and dispose of the cleaning acid and alkaline chemicals used in this process.

Preventative treatment continues to be the best method, to avoid rouging, and save cost and down time in the long run. Choosing the right equipment and process environment, regular inspections, as well as scheduled CIP treatments throughout the life of the equipment are very effective in maintaining equipment. Routine cleaning to remove organic residues with an alkaline cleaner and low concentration acid rinses can be used periodically to avoid severe rouging that will be time-consuming and expensive to correct.

Sources

Anderson, John. ” Classifying Rouge Helps Define Remediation Procedures”. Pharmaceutical Technology, Pharmaceutical Technology, Volume 36, Issue 9. 2 Sep 2, 2012 https://www.pharmtech.com/view/classifying-rouge-helps-define-remediation-procedures

Chai, Richard. “Rouge Formation and Remediation”, 20 Sep, 2019 Aseptic Summit. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/rouge-formation-remediation.pdf?sfvrsn=970e9a8e_8

Drew C. Coleman Daryl L. Roll, “Corrosion Investigation of Pharma Clean Steam Systems” May-Jun 2017. https://ispe.org/pharmaceutical-engineering/may-june-2017/corrosion-investigation-pharma-clean-steam-systems

Lopolito, Paul. “Addressing Rouge in Bio-Pharmaceutical Systems”. 15 Sep 2010 Equipment and Processing Report Pharmaceutical Technology. https://www.pharmtech.com/view/addressing-rouge-biopharmaceutical-manufacturing-systems

Sakly, Mongi. “Coming to basics on Rouging” A3P Association. https://www.a3p.org/en/coming-to-basics-on-rouging/

Sandle, Tim ” The Rouging Effect in Pharmaceutical Water Systems: Causes and Strategies for Prevention” 31 Mar , 2015. IVT Network. https://www.ivtnetwork.com/article/rouging-effect-pharmaceutical-water-systems-causes-and-strategies-prevention

Shah, Sadiq “Derouging and Passivation” 29 May 1998, Pharmaceutical Online https://www.pharmaceuticalonline.com/doc/derouging-and-passivation-0001

Equipment and Processing Systems

Pharmaceutical and Bio-pharmaceutical Processing is subject to very high standards of hygiene and sanitation, so choosing the right materials for the fabrication of processing equipment is of vital importance. The industry is heavily regulated and manufacturing materials must pass rigorous standards so as not to alter or compromise the purity of the products being manufactured.

Stainless Steel

Stainless Steel has long been the preferred material for pharmaceutical applications because of its corrosion resistance and excellent durability. Stainless steel is called “stain-less”, because of its ability to resist corrosion or “stains”. It contains chromium which reacts with oxygen on the surface to create a thin protective barrier. This corrosion resistant property makes stainless steel the preferred substrate for good manufacturing practice (GMP) applications, especially for surfaces with product contact.

There are over 200 different types of stainless steel with different properties that suit various customer requirements. Certain grades of stainless steel are inert to most acidic and alkaline liquids which helps to avoid the risk of contamination. Stainless steel can withstand the aggressive cleaning routines required by the pharmaceutical and bio-pharmaceutical industries, including high pressure washes, or chemical washes.

Benefits of Stainless Steel for Pharmaceutical Manufacturing

Corrosion Resistance

In the strict manufacturing environment standards of aseptic manufacturing, the integrity and sterile nature of the system must be preserved. If corrosion leads to contamination entire batches of product will need to be discarded and the equipment will be out of commission. Stainless steel provides good resistance to harsh chemical compounds, rigorous cleaning processes whether Clean-in-Place, or cleaning after batch operation.

Heat Resistance

Stainless steel is highly stable under different environmental conditions. It has a high temperature tolerance which makes it ideal to withstand heat-based sanitation.

Durability and Ease of Use

Stainless steel is a highly durable material with good formability and can be used to manufacture mixing vessels, pumps, piping, storage tanks, valves and other parts easily.

Aesthetic Appearance

Stainless steel’s property of corrosion resistance makes it easy to clean and maintain, so it continues to look new. Equipment is electropolished to enhance the cleanability, passivity, and appearance of the equipment.

Adam Fabriwerk has decades of experience manufacturing equipment for the pharmaceutical and bio-pharmaceutical industries, and our high quality equipment and vessels are manufactured with the grade of stainless steel that is most suited to the final application.

Austenitic stainless-steel series (e.g., 304, 304 L, 316 and 316L) is widely used pharmaceutical applications because of excellent corrosion resistance, ease of fabrication and affordability. L stands for a low content of carbon (304L and 316L has a 0.03% carbon maximum as compared to 0.08% in 304 and 316 grade).

Grade 316, 316L has better chemical resistance than Grade 304, 304L and is mainly used in applications that have contact with chemical product. 316 contains 2% molybdenum whereas 304 contains no trace of molybdenum . The molybdenum added to grade 316 increases corrosion resistance, makes the grade stronger and more durable, and increases its ability to resist acids and chlorides.

Less often used, Alloy 904L, is also a low carbon austenitic stainless steel that is designed for moderate to high corrosion resistance in a wide range of process environments. It has a high chromium and nickel content, as well as molybdenum and copper which gives it excellent corrosion resistance. The copper improves its resistance to strong reducing acids, and the increased content of nickel and molybdenum makes it resistant to stress corrosion cracking. 904L is also highly scratch resistant because it has a much higher Rockwell hardness.

Super Alloys

Superalloys are complex, high-performance alloys, with a high tolerance of oxidising environments and high temperatures. They maintain their strength and corrosion resistance in the harshest of conditions and severely corrosive environments. Use of super alloys are prevalent in the aerospace, health, energy, oil & gas, chemical processing and pharmaceutical industries.

Hastelloy C-22 alloy is one of the most versatile nickel-chromium-molybdenum-tungsten alloys. This alloy has improved resistance to corrosion vs stainless steel due to its higher percentage of nickel. C-22 demonstrates improved corrosion resistance to both uniform and localized corrosion. C-22 is used in severely corrosive media with high chloride and temperature applications such as buffer solutions, active pharmaceutical ingredients (API), fabric softeners, cleaning supplies etc. C-22 alloy is recognized by the ASME BPE standard, and by the U. S. FDA

Within the strict regulatory norms of the pharmaceutical industry, Adam Fabriwerk is well versed in using stainless steel and other high performance alloys across the different process equipment and fabrication vessels, to offer the best corrosion resistance, aesthetics and longevity of the equipment.

Sources

Free, Michael L. “Why doesn’t Stainless Steel Rust” Scientific American, 12 March 2001, https://www.scientificamerican.com/article/

Pharma Pathway “Pharmaceutical Stainless Steel – Types, Composition & Difference”, 30 March 2020, https://pharmapathway.com/pharmaceutical-stainless-steel-types-composition-difference-2/

Brothers, Eric. “Superalloys use growing rapidly – Frost & Sullivan”, 23 April 2020, https://www.aerospacemanufacturinganddesign.com/article/superalloys-use-growing-rapidly-frost-sullivan/

Pharmaceutical Online, “Hastelloy C-22”, https://www.pharmaceuticalonline.com/doc/hastelloy-c-22-0002

AZoM, “Stainless Steel – Grade 904L” 7, Nov 2001, https://www.azom.com/article.aspx?ArticleID=1022

When considering the manufacture of Pharmaceuticals and Therapeutics, viscosity is a key factor and must be precisely managed. The viscosity of liquid and semi-solid preparations has to be maintained batch-to-batch to ensure uniform drug potency through all stages of production. Testing the viscosity is a very important practice by quality control in the pharmaceutical manufacturing industry.

What is Viscosity?

Viscosity is a measure of a fluid’s resistance to flow i.e. the measure of a substance’s resistance to motion under an applied force. A fluid with large viscosity resists motion because its molecular makeup gives it a lot of internal friction. For liquids, it corresponds to the informal concept of “thickness”: for example, syrup that is thick and flows slowly has a higher viscosity than water which is thin and flows quickly.

A material’s viscosity is not a single value, instead it is a property of fluid that depends on the conditions of measurement (shear rate, temperature etc). If the viscosity of a fluid remains constant regardless of changes to the shear rate, we call these fluids Newtonian fluids. If viscosities fluctuate depending on the shear rate, these are called Non-Newtonian fluids. Liquids with a viscosity of zero are called “superfluids.”

Viscosity in Pharmaceutical Preparations

Liquid dosage forms, (suspensions, emulsions, and dispersions) have different applications in the pharmaceutical industry. They may be delivered via oral, parenteral- (injectable, inhalation, ophthalmic, otic, nasal) or topical routes. Parenterals are usually sterile formulations, whereas liquid orals and topical solutions are non sterile. Each of these forms has different standards to maintain and challenges to overcome in maintaining the viscosity of the product, depending on end use performance. For instance, cough syrup should be drinkable but still have viscosity high enough to coat the throat, and ointments should have higher viscosity but still squeeze easily out of the pack, and be easy to spread.

This becomes extremely critical during the manufacturing, mixing and blending and filling process. The viscosity of the material has a direct effect on industrial mixer specifications when designing a manufacturing line for pharmaceuticals. The design of the mixing vessel, the type and power of the motors and pumps, the type of product filters, and quality control measurement equipment will depend on the viscosity of the manufactured solution.For example fluid viscosity will affect how it will behave with an agitator and pump. A high viscosity liquid will be harder to move than a “thinner” low viscosity liquid. Selecting the right mixing vessel, and agitator is vital for mixing efficiency. Material densities, shear characteristics, and blend time are all factors to consider when designing an efficient system.By controlling the size and shape of the vessel, selecting the right agitator, and controlling the automation we can produce precise solutions every time.

The mechanical design of the process vessel and the skid is designed keeping in view the viscosity of the product. For processing viscous products, anchor agitators with scrappers with high shear mixers are often used. Biopharmaceuticals demand low shear mixing where magnetic mixers are used effectively.

Viscosity checks should ensure the correct consistency of the end product to meet customers’ expectations. Manufacturing consistency can be acheived through proper design and automation of the entire system, through equipment that utilizes continuous real-time viscosity measurements. If the manufacturing equipment is not designed with these considerations in mind this will result in reduced product quality, and increased cost and wasted materials during the manufacturing process. To ensure consistent manufacturing, the right vessels and equipment must be designed and engineered, changes in viscosity throughout the process should be monitored, and adjustments made to ensure regulatory compliance, integrity and consistency of the manufactured solution.

Pharma and Bio-Pharma Process Equipment

Adam Fabriwerk uses radar level measure technology from Vega to measure level changes in hygienically demanding process vessels for Pharmaceuticals and Bio-Pharmaceuticals. In their article “A Clean Switch” Vega highlights the benefits of VEGAPULS 64 for reliable and continuous monitoring of levels in mixing vessels.

Excerpts from the Article

“Antibiotics, blood plasma products as well as injection and infusion solutions are among the products manufactured by [Adam Fabriwerk]. After production, the materials are transferred directly to the filling stations. Adam Fabriwerk not only makes the vessels, they also equip them with the necessary infrastructure. This ranges from magnetic mixers and buffer and storage containers to CIP modules for lyophilizers and sterilization modules for the biopharmaceutical industry. Not only the vessels themselves must comply with the strictest hygienic requirements, but also all components and in particular the elements connecting to other systems.”

“Each step is therefore monitored by a sophisticated quality assurance system that meets all FDA requirements. An important aspect here are the customer-specific control concepts for the widely different automation levels. To ensure a reliable process, the level in the mixing vessel must be reliably and continuously monitored.”

“The company of course already knew about the advantages of radar level measurement technology. After all, the method is not only very accurate, but it also measures independently of temperature and pressure as well as the density of the liquid. What is more, the measuring instruments can be easily and quickly installed and put into operation. The most important aspect in pharmaceutical applications, especially in view of the large agitators: the sensors measure contactlessly.”

“Once installed, radar sensor VEGAPULS 64 didn’t need to be reconfigured, not even during CIP cycles. This has a particularly positive effect when the vessels are delivered to the pharmaceutical manufacturers. The sensors can be adjusted and adapted to the vessel before delivery. The end customer thus receives a fully operational system. Adam Fabriwerk was enthusiastic about the uncomplicated collaboration with VEGA and the simple installation of the new sensor.”

Read the entire article posted on the Vega Instruments company blog here.

Adam Fabriwerk Processing Systems for Pharmaceuticals and Bio-Pharmaceuticals come with Automation Systems that are driven by highly reliable and accurate instruments and controls that deliver consistency and repeatability.

Surface Finish is incredibly important for high purity systems in pharmaceutical equipment since hygiene is of utmost importance when processing and manufacturing pharmaceutical products. The surface of metal parts in Pharmaceutical equipment, including tanks, vessels, valves, pumps and other accessories needs to be perfectly smooth, free of anomalies and other contaminants left behind by mechanical polishing. Electropolishing is one of the most popular finishes for pharmaceutical applications and provides several crucial benefits.

In electropolishing, the metal object to be electropolished is immersed in an electrolyte, and subjected to an electrical current, that strips the top layer of the metal, removes impurities and contaminants, and smooths surface roughness, nicks, bumps leaving a fresh clear layer at the surface. As the metal parts are totally submersed in the bath during electropolishing, it can reach all surfaces, and hard to reach spots on the equipment.

Benefits of Electropolishing in the Pharmaceutical Industry

Enhanced Appearance

Electropolishing leaves a bright, reflective finish which will not crack or peel. The surface has a uniform lustre and is aesthetically pleasing. It can improve surface roughness by up to 50% by levelling micro-peaks and valleys, on the metal’s surface.

Ease of Cleaning and De-Contamination

Electropolishing removes tiny burrs that can trap contaminants and allow product adhesion, making the smooth surface of an electropolished metal easy to clean and sterilize. It eliminates the build-up of bacteria, and prevents catalytic reactions of surfaces, so equipment can be cleaned and sterilized with less time and air/water pressure. Electropolished surfaces do not allow product to stick to it, and keeps it moving smoothly though the processing system.

Greater Protection from Corrosion

The electropolishing process removes the outermost surface layer of stainless steel, eliminating deeply embedded contamination. It can also draw out other contaminants in metal such as iron, carbon, oxidation from welding and other surface contaminants that can create corrosion and rust. The smooth, ultra-clean surface of an electropolished metal, also reduces product adhesion and improves corrosion resistance.

Improved Structural Integrity, and Enhanced Mechanical Properties

Tiny anomalies in metal surface can affect the fit and function of a component and lead to premature failure in the machinery. Electropolished surfaces are microscopically smooth and reduce friction of parts in pharmaceutical machinery. By removing the surface layer of metal, electropolishing can also improve structural integrity of parts that can be weakened by surface cracks, nicks, scratches and fabrication stresses during the manufacturing process. This increases the life cycle of the equipment leading to reduced downtime and lower costs.

Adam Fabriwerk processing and storage tanks, vessels, storage, batch mixers, filters, piping and other pharmaceutical and bio-pharmaceutical equipment parts are electropolished as per ASME BPE specifications. The standards incorporate best-practices for enhancing product purity and safety and maintain high levels of hygienic requirements of the materials used. Compliance with these standards is critical in the pharmaceutical industry to ensure the products produced are safe, hygienic, and of a high quality.

At Adam Fabriwerk, we take safety of our employees and emergency response procedures very seriously. Fire Safety training, Health and Safety training, and Emergency Drills are a must for all occupants of our manufacturing premises.

Spread over an area of 15000 sqm Adam Fabriwerk has one of the largest manufacturing facilities in India, for engineering processing machinery for the Bio-pharmaceutical, Pharmaceutical, Cosmetic and Allied Industries. We are supported by over 200 employees who are an mix of engineers, process experts, trained technicians and skilled fabricators and project managers.

To protect our employees and prevent loss from fire, we rely on regular trainings and defined emergency processes. Adam Fabriwerk conducts periodic Fire Safety Training to a carefully selected fire-fighting committee. This training course, led by professional trainers, includes both theory and practical components to ensure that the occupants can safely handle workplace emergencies, and work toward making workplaces safe. Training in classroom via presentations, including audio-visual material in addition to practical training is conducted to ensure occupants know both precautions and procedure to avoid or control fire.

What is Covered Under the Training

• Use of various types of fire extinguishers, Fire Blanket & Fire Hose Reel scenarios
• First aid
• Shutdown procedures
• Chemical spill control procedures
• Search and emergency rescue procedures

After the training Adam fabriwerk staff are trained and ready to tackle workplace emergencies armed with with general knowledge on how fires can start or spread, recognizing the alarm, classes of fire, taking appropriate action in case of an emergency, providing assistance to others who need help, the location of fire extinguishers and other safety equipment, identification of all exits and fire safety doors, eveacuation routes and procedures and instructions on how and when to use fire protection devices.