In pharmaceutical operations, it is crucial that process reliability is always high and consistent. Central to this aim is timely measurement of analytical parameters. Although analysis of grab samples offers accurate results, it is time-consuming, carries the possibility of sample contamination, and does not supply continuous, real-time data. On the other hand, in-line measurement using process analytical equipment reduces the workload of laboratory staff; measures directly in the process, eliminating the possibility of false readings due to contamination; and supplies a constant stream of real-time measurements, allowing rapid corrective action when necessary. Most significantly, in-line analytical measurements enable reliable, repeatable production of high quality pharmaceutical products, batch after batch.
Achieving the Highest Level of Performance in Bioreactor Process Control
This eBooklet highlights different analytical measurement challenges during biopharmaceutical fermentation and explains the value of implementing in-line process analytical equipment to enable reliable, repeatable production of high quality pharmaceutical products, batch after batch. Several critical processes are outlined in case studies, in which solutions and their implementation are detailed.
Process Analytical Solutions - Optimizing Pharmaceutical Processes
Production processes and Purified Water quality can be assured through monitoring analytical parameters. For every stage of the manufacture of pharmaceuticals, METTLER TOLEDO in-line measurement systems deliver accurate, real-time evaluation of process conditions.
Applications
From water preparation to chromatography
Pharmaceutical grade water preparation
Pharmaceutical waters are a multi-functional resource, crossing all disciplines in the pharmaceutical industry. Water is used as a raw material, solvent, ingredient, reagent, and cleaning agent, and is produced in a variety of “pure” forms. The wide variety of pharmaceutical waters and water systems means their production is becoming an increasingly specialized process that requires highly dependable instrumentation. For continuous assurance of water quality, on-line measurement of TOC, ORP and conductivity is essential.
Inoculum preparation / Starter culture
Inoculums are pure cultures of microorganisms used for fermentation processes. The size and the quality of the starter cultures is very important to keep fermentation processes sustainable. pH and DO measurement is essential for optimal starter culture growth conditions. pH affects the activity of enzymes and DO control ensures adequate supply of oxygen for respiration.
Nutrient media preparation
Media is used in biopharmaceutical operations to promote bacteria growth. Growth conditions are heavily dependent on pH, and by properly adjusting pH in the media, cost savings can be achieved through decreased acid/alkaline dosage during inoculum and production fermentations.
Fermentation / Cell cultures
During fermentation processes, data from analytical measurement systems enables the maintenance of consistent living conditions for the production of microorganisms or suspended cells. Important parameters for monitoring the physiochemical environment are pH, dissolved oxygen, dissolved carbon dioxide, and turbidity. Control of these four parameters leads to maximized process yield, batch to batch consistency, reduced product loss and quicker batch runs. It also ensures that optimal growth conditions are constantly met.
Separation
Separation processes are critical steps in the production of biological products, as they directly affect product consistency and yield. Separating the cells is generally carried out by centrifugation or filtration. Controlling separation by turbidity based on loading, leads to greater efficiency and productivity from the filtration process.
Buffer preparation
Buffers are liquids usually consisting of water, salts and pH adjusting chemicals. They are used as a liquid phase in chromatography, dialysis and other processes. Correct pH is essential for buffer accuracy to ensure high resolution purification and increased reproducibility.
Chromatography
Chromatography plays an important role in the purification of pharmaceutical products derived from biotechnology processes. It isolates and purifies the product of interest. Maintaining precise pH and conductivity levels is critical in liquid chromatography.
Publications
From whitepapers to webinars
Brochures
Production processes and Purified Water quality can be assured through monitoring analytical parameters. For every stage of the manufacture of pharmac...
Application notes
This application note explains the temperature compensation in pharmaceutical water compliance.
The United States Pharmacopeia (USP), European Pharmacopeia (EP) and all other Pharmacopoeias set strict guidelines for water quality and test equipme...
Ozone (O3) is an unstable tri-atomic form of oxygen. It is a very strongly oxidizing gas that is injected into water to remove organics that may contr...
A leading global supplier of generic pharmaceuticals was able to enhance process safety and operational efficiency during centrifugation by using a ME...
In many ways, analytic measurements are at the heart of your process efficiency. Therefore, the lower your downtimes and maintenance requirement, and...
This Application Note discusses the use of TOC in Clean In Place and cleaning validation technologies.
White papers
Pharmaceutical manufacturers need to focus on quality and cost efficiency. Traditionally, the pharmaceutical industry evaluates quality on samples tes...
The Quality by Design methodology and the Process Analytical Technology initiative help pharmaceutical manufacturers to produce products with consiste...
Dissolved ozone is an effective sanitizer for pharmaceutical and personal care products water systems.
This article discusses real time TOC monitoring in the water purification process and the importance of rapid, continuous and reliable TOC measurement...
Regardless of the production location of pharmaceutical products, the manufacturing company must meet the Pharmacopeia (USP, EP, ChP, JP, IP) requirem...
For a producer of medical biopolymers, a solution employing Thornton in-line multi-parameter measurements has significantly increased real-time respon...
Increasing worldwide demand for vaccines is resulting in manufacturers changing their production methods.
Competence Center
To enable ideal growth conditions, batch-to-batch consistency and to achieve high yield and quality in Bio Pharmaceutical, Chemical Pharmaceutical pro...
Webinars
Ozone is an effective sanitizing agent in water used for pharmaceutical and personal care products. Ozone sanitizes the water, rapidly destroying any...
eBooklet
This booklet highlights different analytical measurement challenges during biopharmaceutical fermentation that pharmaceutical companies may face when...
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