AsianScientist (Oct. 28, 2021) – When it comes to successfully developing and producing pharmaceutical drugs, consistency is key. Not only should such medications be safe and effective, but they should also be contaminant-free and reliable—performing in a predictable fashion as needed.
Though all these requirements may seem like a tall order, achieving them is entirely possible through a set of practices known as quality control (QC). From confirming sterility to monitoring air for microbes, these practices help ensure product consistency and safety from start to finish, forming an essential backbone of the development process.
Through its portfolio of tools and products, biopharmaceutical solutions provider Sartorius empowers researchers and companies to place QC front and center. Read on to find out more about Sartorius’ extensive suite of QC solutions.
Solutions made to measure
Even in the earliest stages of research and development (R&D) for a new formulation, maintaining quality is paramount. Take for instance sample preparation—which typically happens at the very beginning of every biopharmaceutical production process.
Though weighing reagents seems deceptively simple, anything from the laboratory’s air conditioning to the room’s humidity can directly impact the scale, leading to errors that can accumulate over time if not immediately addressed. For all these environmental factors to be accounted for, balances typically need to be recalibrated frequently, adding further steps to the workflow.
To streamline the process and keep these factors in check, Sartorius’ Cubis® II Balance monitors and detects any changes in ambient conditions, like temperature, humidity and air pressure. In contrast to manual recalibration still done by many laboratories, the Cubis® II can automatically calibrate and readjust itself to compensate for these conditions—keeping the measurements precise and accurate even amid varied environmental conditions.
But sometimes, the problem lies within the sample itself. For instance, some samples or containers can become charged with static electricity, attracting stray particles and leading to fluctuations in weight. Static electricity can arise from even the most mundane laboratory duties, such as drying a glass beaker—with the effect increasing especially as humidity drops inside the room. To counteract the effects of static electricity, the Cubis® II has a built-in ionizer to eliminate the interfering electrostatic particles, keeping samples charge-free and measurements error-free.
Safer by design
Across all organizations, QC functions as a crucial backbone, helping ensure a high and consistent standard throughout the process. Within the context of drug development and manufacturing, one element of QC would be the microbial enumeration test, which identifies microbial contamination—whether in the form of fungal spores or bacteria.
Another key element of QC is bioburden testing for microbial contamination control. For instance, contamination usually occurs when the membrane is transferred for microbial quantification. Sartorius’ Microsart® series solves this problem with its @filter and @media system, a touch-free method that allows the user to effortlessly position the membrane onto the agar plate. In a single turn, the plate is locked and ready for incubation, reducing the risk of contamination and false positive results.
Meanwhile, to ensure that ambient air in the facility is free from contaminants, the MD8 Airscan® uses a gelatine membrane filter to capture even the smallest airborne microbe over a period of eight hours. The membrane filter can then be incubated on an agar plate or dissolved for other further applications, allowing the identification of any contaminants.
Moving further downstream, before pharmaceutical products can be sold and distributed, they must first be tested and certified for sterility. Sartorius’ Sterisart® NF System rises to the challenge with innovations like the Sterisart® Septum, which acts as an easy-access sampling port that does not compromise the integrity of the sample canister’s closed system. Thus, the Sterisart® NF System ensures maximum safety and sterility without compromising canister integrity.
From start to finish, Sartorius’ solutions supports QC throughout the entire pharmaceutical workflow. By streamlining processes and offering innovative alternatives to traditional methods, such solutions—though small in size—translate into huge time and energy savings. With the help of Sartorius’ toolkit of QC products, pharmaceutical companies can develop and manufacture game-changing drugs with ease.
To learn more about Sartorius’ array of QC solutions, watch their webinar on-demand at: How to Increase Productivity and Efficiency in Pharmaceutical Quality Control Labs | Sartorius
Asian Scientist Magazine is a media partner of Sartorius.
Copyright: Asian Scientist Magazine; Photo: Sartorius
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