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Pharmaceutical Manufacturing

Pharmaceutical fluid handling equipment

Pharmaceutical processing is a precise field focused on creating medications like tablets and injectables. It adheres to strict quality and safety standards to ensure effectiveness and compliance with international regulations. This vital industry plays a crucial role in global healthcare.

Pharmaceutical Technology can be defined as all technologies related to the development (including analysis, test, research and development, and quality control) of a pharmaceutical form using natural, semi-synthetic, and synthetic active and auxiliary substances and industrial production.

Pharmaceutical technology includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other practices used in diagnostic and determinative procedures and the treatment of patients.

Pharmaceutical manufacturing is the industrial-scale development of pharmaceutical drugs by pharmaceutical companies. The process of pharmaceutical manufacturing can be broken down into a series of unit operations.

The sterile and non-sterile pharmaceutical manufacturing process needs to be designed and operated to minimize microbial contamination. Good design practices require an assessment of hazards and a calculation of risks, together with risk mitigation strategies.

A purposefully designed monitoring regime can achieve a correct risk-assessed process. The scope of such assessments needs to begin with supplier assessments and control of incoming raw materials through to distribution of the manufactured pharmaceutical product.

Pharmaceutical fluid handling equipment includes a wide variety of equipment, such as (metering) pumps, capsule equipment (filling, sorting), mixing equipment, thermal processing equipment (coolers, chillers, dryers, heat-exchangers), (x-ray) inspection systems, and tanks for holding liquids.

To guarantee precise manufacturing and formulation development, nearly every process can be automated. Resultantly, there is a piece of pharmaceutical manufacturing equipment involved in every processing step.

Fluid handling trends in pharmaceutical processing - Fluid handling technology in pharmaceutical processing

Hygienic fluid handling systems

Product integrity is crucial in the pharmaceutical industry. The highest sanitation standards must be observed for a product to maintain the same characteristics in every production batch.

In pharmaceutical processing industries, measuring and controlling the flow of liquids and gases demands exceptional process instrument performance and networkability.

Process systems for the preparation of pharmaceutical liquids

Production of pharmaceutical liquids is carried out in temperature-controlled stainless-steel tanks with stirring units under the addition of chemicals with or without nutrient solutions.

A complete understanding of the pharmaceutical production process is critical for the correct design. Clear definition, assessment, monitoring of essential parameters directly affecting product quality are the baseline for applying suitable process systems granting complete in-line and at-line quality control.

The vast majority of liquid pharmaceutical solutions require a variety of tankage, piping, and ancillary equipment for fluid mixing, filtration, transfer, and related activities. Suspensions, ointments, and other similar products, including the preparation of the solutions for freeze-dried products, can be manufactured in the same or very similar equipment.

Commercial liquid dosage manufacturing reaches large-scale production after being preformulated at the laboratory level, followed by formulation at the small scale and then at the pilot plant scale.

Due to the complexity of the liquid dose manufacturing process, scale-up from pilot to commercial production is not a simple extrapolation.

The primary ingredient in most liquid dose manufacturing processes is water. While it is the safest and most palatable solvent option, water quality is significant for the stability of pharmaceutical dosage forms.

Liquid pharmaceutical dosage forms

Liquid pharmaceutical dosage forms are essentially pharmaceutical products that involve a mixture of active drug components and nondrug components (excipients).

Liquid pharmaceutical dosage forms are prepared:

  • By dissolving the active drug substance in an aqueous or non-aqueous (e.g., glycerin, ether, alcohol) solvent,
  • By suspending the drug in an appropriate medium, or
  • By incorporating the drug substance into an oil or water phase.

Pharmaceutical fluid handling equipment and fluid handling technology

 

Sterile liquids manufacturing is universally acknowledged as the most difficult pharmaceutical production process.

When these products are manufactured using aseptic processing, poorly controlled processes can expose the patient to an unacceptable level of contamination.

The production of sterile liquid products requires fastidious design, operation, and maintenance of facilities and equipment.

It also requires attention to detail in process development and validation to ensure success.

Sterile liquids manufacturing is heavily impacted by formulation and the selection of primary packaging components.

The pharmaceutical processing industry is under constant pressure to increase efficiency, reduce costs, and maintain quality.

Forward-thinking pharmaceutical processing companies have invested in more innovative manufacturing and consider moving to a continuous manufacturing process.

The goals are clear, build in regulatory compliance, ensure close monitoring of processes, de-risk the manufacturing chain and enable fast drug release.

In pharmaceutical technology, the market has been increasing standardization in high added value equipment for years. Examples of this trend are autoclaves, freeze dryers, filling lines, distillers, etc.

However, when it comes to processing equipment for preparing, storing, and transferring liquid pharmaceuticals, no studies of needs and applications exist to date at the level of both engineering and pharmaceutical technology.

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Experts for Pharmaceutical Manufacturing

Dave is Vice President of Sales at Hawk Measurement (HAWK) and has more than 40 years of experience in the process instrumentation industry. Dave started working as an outside sales engineer in 1979 for his father’s company, AO Grumney. While there, he learned the importance of value added selling and superior customer support. He later became a manufacturer’s rep for various companies such as Siemens, Miltonic’s, AMETEK and many others. Several years later, Dave started his own company, Delta Instrumentation, a manufacturers’ rep agency which serves the process instrumentation and automation industries. In 1989 Dave started FLO-CORP, a US manufacturing company of flow, level and monitoring instrumentation. Through manufacturing his own line of process instrumentation, he found it allowed him to gain more control over origin of product, quality and lead times. In 2019, FLO-CORP merged companies with Hawk Measurement, the world leader in level, positioning, asset monitoring and flow measurement technology that provides cutting-edge equipment and complete solutions to the global industrial market. Throughout his wide range of experiences as sales engineer, sales rep, president, owner and CEO, the position he currently holds at Hawk Measurement as VP of Sales, allows him to do what he loves. Dave has always had a passion for meeting new people, building relationships and helping customers solve problems. His values align with HAWK’s as they are committed to providing best-in-class products, services and technologies that will have unsurpassed value to their customers.
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Dietmar Saecker is temperature measurement expert at Endress+Hauser in Nesselwang, Germany. His experience covers technical sales support, consulting for difficult temperature measurement applications and international know-how transfers, especially in the Life Sciences industry. He also teaches at the Kempten University of Applied Sciences. Dietmar studied Chemical Engineering with a focus on measurement and control technology at the University of Dortmund. Experience from many customer visits has shown him that many problems arise from an incorrect choice of equipment. In lectures and training courses on temperature measurement technology, he demonstrates the complexity of the subject and regularly surprises numerous listeners with his thoughts and experiences. His recipe: “Recognizing trends and sharing knowledge. Because only when we share knowledge can we develop better solutions together.” Dietmar is looking forward to your questions and the exchange with you.
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Erik Tiemensma, Sales Knowledge Manager, has over 20 years of experience in flow and pressure measurement and control for gas, liquid and vapour. For many years Erik worked as Sales Engineer supporting worldwide sales channels in finding the best solutions for customers’ applications. At Bronkhorst we are convinced that sharing experiences and knowledge is an added value for customers, when discussing the most suitable products for their applications. As part of this expert panel, looks forward to your challenging flow or pressure questions.
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Hello, my name is Lee Sandry and I am a Sector Training Manager at Watson-Marlow Fluid Technology Solutions. My role primarily involves training sales colleagues to provide customers the best fluid handling solutions in industrial sectors, including water treatment, mining, chemical and construction applications. Being from Cornwall and surrounded by the mining industry, with a father who worked underground, my local environment was always about engineering and mineral processing. My apprenticeship when I left school was with the large mining machinery manufacturer, which has led me onto greater things. My background at Watson-Marlow started in 1996 when I was involved in the production of hundreds of parts that go into the manufacture of our pumps. This was followed with becoming a Technical Support Engineer, working directly with colleagues and customers globally. Site visits and constant customer-facing support at Watson-Marlow Fluid Technology Solutions, gave me the opportunity to experience many aspects of installation and operation of our peristaltic and sinusoidal pumps range. My aim is to enable sales teams around the world to provide robust solutions for demanding pumping applications, helping customers improve the efficiency and safety of their manufacturing process. Choosing the right pump can overcome problems that cause other pump types to fail. With no rotors to wear, or seals and glands to flush, peristaltic hose pumps handle abrasive fluids without the maintenance costs of other pumps. Whilst the extremely low shear and high suction sinusoidal pumps reduce product damage and cut waste in high viscosity fluid transfer duties.
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Natalie Waldecker, Portfolio Manager Food and Pharma, knows the challenges of the demanding industries inside out. With her broad application knowledge, she is at home on topics such as hygiene design, certificates and cleanability. As product manager for pressure measurement technology, she is also responsible for one of the most important measuring principles for the industry. Natalie gathers her knowledge as close to the application as possible. Preferably directly at the customer’s site, experiencing “real world” practice. She has thus gotten thoroughly acquainted with international customer requirements and knows the ins and outs of the market. With this background, she is able to not only explain technical relationships in an understandable way, but also offer valuable tips and convincing solutions. In the 12 years she has been with VEGA, she has steadily improved her expertise which makes her the right person to contact for new product ideas and tailored customer solutions.
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Trevor Forster is Managing Director of the internationally respected flowmeter company – Titan Enterprises Ltd. His experience in fluid handling dates back to the mid 1960’s when he started working on rotating seals and flowmeter design for third party clients. Trevor draws upon his extensive experience of using innovative design and production techniques to produce elegant flow metering solutions for organisations around the globe. Titan Enterprises supply a range of off-the-shelf flowmeters, application-specific flowmeters & bespoke flow metering devices & solutions. Their flow sensors are designed to customer specifications & to meet specific flow ranges & environmental conditions.Titan are also a supplier of NSF-approved flowmeters for food & beverage applications.
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Matt Smith is Sales Director at Silverson Machines, which has over 70 years of experience helping customer in the field of high shear mixing. Silverson Machines serve many different industries from Pharmaceuticals to Food and can be used in a variety of applications including emulsifying – creating stable emulsions, blending liquids of varying viscosities and homogenisation. Along with a dedicated and knowledgeable Sales team and Technical staff, Silverson Machines can help find the right mixer for your application.
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