Pharmaceutical Manufacturing

Pharmaceutical manufacturing process

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

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.

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 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.

Sterile liquids manufacturing

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.

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 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.