Drug manufacturing is the industrial-scale production of drugs by the pharmaceutical industry to provide a continuous supply of drugs of consistent quality.
To overcome the pressure from investors, patients, and regulators, pharmaceutical manufacturing must find solutions to enable fast drug release and reduce costs while maintaining quality.
Selecting the correct technologies and instrumentation to monitor quality throughout the process is critical to drug manufacturing.
METTLER TOLEDO industrial weighing, process analytics, particle characterization spectroscopy, spectroscopy, laboratory weighing and analytical technologies perfectly fit the requirements for in-process monitoring and post-production quality testing.
Combined with METTLER TOLEDO software, they ensure traceability and compliance with FDA 21 CFR Part 11.
During chemical drug manufacturing, the active pharmaceutical ingredien (API) is mostly made following chemical reactions (synthesis, biocatalysis, biotransformation, extraction, etc.) performed in series, where the product from one step becomes the starting material for the next step until the final API is obtained.
The products are isolated and purified in between steps by evaporation, crystallization, filtration, or chromatography.
While most chemical or biochemical APIs are produced through batch reactions over a defined period, many companies are considering moving to automated, continuous manufacturing processes to gain in cost and efficiency.
Good Manufacturing Practice (GMP) regulations state that quality should be built into each stage of the manufacturing process through:
Companies are therefore investing in process analytical technology (PAT), quality by design (QbD), and hygienically designed equipment.
Each step of the process - including the income of the raw material, the final drug dosage form, parameters influencing the synthesis and extraction processes, as well as variables affecting the quality of the final drug product - are monitored to ensure product consistency and minimize risks.
Products are weighed to verify quality between every step and at completion.
While traditional weighing systems may be less reliable, the rise of Industry 4.0 introduces easy-to-integrate smart weighing systems that are becoming the norm, enabling condition monitoring and active alerts.
Real-time process monitoring provides knowledge and information that ensures the quality of the molecule is met and maintained, allowing decisions on product quality to be made in situ, without relying on offline quality assurance and control. Real-time analytics comprise:
In-line pH, ORP, CO2, oxygen, temperature, and pressure
Compositional monitoring using spectroscopy such as FTIR and Raman
Particle size and particle size distribution using particle characterization spectroscopy
Weight-based filling and dosing with smart, connected weighing devices
Hygienically designed instruments facilitate an efficient manufacturing process, guarantee product quality, prevent cross-contaminations, and ensure regulatory compliance.
Instruments involved in chemical drug manufacturing, such as weighing equipment and process analytic sensors, should be chosen with regard to GMP guidelines and current practices in cleaning and validation.
METTLER TOLEDO Service is your one-stop shop for all your balance service, scale service, and inspection device service needs.
Our global network of factory-trained technicians is dedicated to providing expert care for your devices throughout the lifecycle.
From installation and initial calibration to preventive maintenance and timely upgrades, we ensure your operations run smoothly and efficiently.
