Pope Vessels and integrated Processing systems are utilized in production, pilot plants and labs for processing pharmaceuticals, biomaterials, foods, specialty chemicals, etc.Read more
Fluid Handling Technology in Pharmaceutical Manufacturing
Pharmaceutical manufacturing has extremely precise requirements and manufacturing guidelines in terms of quality. Therefore, all pharmaceutical manufacturing technology must comply with all required internationally relevant legal, quality, and safety standards. After all, health cannot be compromised. Products are made in larger quantities and this affects the cleaning of the equipment used.
- Pharmaceutical technology
- Pharmaceutical manufacturing process
- Pharmaceutical fluid handling equipment
- Liquid dose manufacturing
- Sterile liquids manufacturing
- Fluid handling trends in pharmaceutical processing
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 the industrial production.
Pharmaceutical technology includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures and the treatment of patients.
Pharmaceutical manufacturing process
Pharmaceutical manufacturing is the process of industrial-scale development of pharmaceutical drugs by pharmaceutical companies. The process of pharmaceutical manufacturing can be broken down into a series of unit operations.
Both the sterile and nonsterile pharmaceutical manufacturing process needs to be designed and operated for that microbial contamination are minimized. Good design practices require an assessment of hazards and a calculation of risks, together with risk mitigation strategies.
A correct risk assessed process can be achieved through a purposefully designed monitoring regime. 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
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.
Hygienic fluid handling systems
Product integrity is crucial in the pharmaceutical industry. For a product to maintain the same characteristics in every production batch, the highest sanitation standards must be observed.
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 full understanding of the pharmaceutical production process is the key concept for the correct design. Clear definition, assessment, monitoring of critical parameters directly affecting product quality are the baseline for the application of suitable process systems granting both 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 liquid 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.
Liquid dose manufacturing
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 major ingredient in most liquid dose manufacturing process 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 in the form that involves 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.
Sterile liquids manufacturing
Sterile liquids manufacturing is universally acknowledged to be 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 both by formulation and the selection of primary packaging components.
Fluid handling trends in pharmaceutical processing
The pharmaceutical processing industry is under constant pressure to increase efficiency, reduce costs, and maintain quality.
Forward-thinking pharmaceutical processing companies have invested in smarter manufacturing and are considering a move 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 the level of 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 process 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.
Articles related to pharmaceutical manufacturing
Admix, Inc., global manufacturer of hygienic and industrial mixing equipment serving the food and beverage, chemical/industrial, cosmetic, and pharmaceutical markets, today announced that its DynaShear inline mixers have been certified by the European Hygienic Engineering & Design Group (EHEDG) for meeting strict guidelines for hygienic design and cleanability.Read more
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Bürkert’s FLOWave liquid flowmeter has received ATEX Zone 2 approval, opening use for OEMs, system integrators and end users in potentially explosive atmospheres for hygienic applications.Read more
TorqSense transducers are used to ensure caps are being properly fitted to pharmaceutical bottles in a high speed packaging line run by the Almac Group at its global headquarters in Craigavon, Northern Ireland, UK.Read more
Active Pharmaceutical Ingredient (API) is the part of any drug that produces the intended effects. Because API manufacturing is the chemical branch of the pharmaceutical industry, it’s subject to the safety and integrity regulations of both the pharmaceutical and the chemical industries.Read more
Excessive gas consumption wastes money – and of greater importance – can affect product quality and safety. The pharmaceutical industry uses large quantities of nitrogen, oxygen, carbon dioxide gas, and air. Without good air and gas flow measurement, cost, quality, and consumer safety will suffer.Read more
Applikon Biotechnology is a global leader in developing and supplying advanced bioreactor systems for the production of vaccines, antibodies, tissues, bio-pharmaceuticals, nutraceuticals and biosimilars in the pharmaceutical industry, as well as enzymes, food, feed, bio-fuel, bio-chemicals and bio-plastics for industrial biotechnology.Read more
The Rotronic HygroLab is out latest high-end laboratory analyzer for water activity measurements with up to four measurement probe inputs. It enables simultaneous or asynchronous measurement with the tried-and-tested AW Quick function for pharmaceutical products, tobacco, coffee, cosmetics, food and many more.Read more
Automated analysis devices are the essential basis for extensive test capacities for the corona virus. Through parallel and faster processes, automation significantly increases the number of tests, saves manpower and ensures process reliability.Read more
Masterflex® expands its portfolio with a new Reglo piston pump for more fluid handling options.Read more