Pharmaceutical Manufacturing

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. 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.

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.

Sanitary centrifugal pumps circulate water for injection and cleaning fluids, while peristaltic, diaphragm and lobe pumps dose active ingredients, excipients and sterile product. Every wetted part has to be documented, cleanable and traceable to a material certificate. More in Pumps and Pumping Systems.

Sanitary diaphragm valves are the default because they are drainable and steam sterilisable with no crevices, supported by zero dead leg point of use valves on water loops and aseptic sampling valves. Surface finish and elastomer choice are part of the validation file. More in Process and Control Valves.

Coriolis mass flow meters dose solvents and actives by weight rather than by volume, which removes the density question entirely. Magnetic meters follow purified water and WFI loops, where the minimum velocity that keeps the loop sanitary is itself a controlled parameter. More in Flow Control and Measurement.

Sterile filtration of product and process gases, prefiltration ahead of it and integrity testing after it are part of batch release. On the utility side, filtration and UV protect the purified water system from bioburden. More in Fluid Filtration Systems.

Magnetic and top mounted mixers homogenise solutions, suspensions and emulsions in vessels that have to stay sterile. Bearingless magnetic drives avoid particle generation, which is why they are common in aseptic filling preparation. More in Fluid Mixing.

Conductivity and total organic carbon monitor purified water and WFI continuously, while pH, UV and near infrared follow the product itself. These measurements are the backbone of process analytical technology and of continuous manufacturing. More in Process Gas and Liquid Analytical Systems.

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