6 July, 2023 |
In our latest podcast episode, host Christian Dunne spoke to CEO and Managing Director of FAMAT Sampling, Jorge Esteban, about the challenges facing companies looking to sample their potent compounds safely, efficiently and in compliance with regulations.
We also explored our recent partnership with Famat to develop the ideal contained sampling solution, a powerful combination of ChargePoint Technology’s split butterfly valve and Famat Sampling’s 125-TC/OEL valve to create a secure environment for powder samples to be taken.
The interconnected system forms an airtight seal that prevents a dead zone and allows samples of highly potent powders to be transferred into containers safely and securely, maintaining OEB4 and OEB5 level compliance.
The sampling revolution: Optimising contained sampling in pharma’s quest for quality
The demand for solutions to streamline process efficiency and maintain GMP integrity, along with product containment during drug development and manufacturing, is rising rapidly.
One area gaining popularity is contained sampling, which enhances quality analysis while minimising risks and improving efficiency.
ChargePoint Technology recently partnered with a sampling device specialist, Famat Sampling, to combat containment and GMP issues that may arise during sampling.
Containment challenges during drug production
Contained sampling during drug production is essential for GMP
1) Maintaining product quality, and sample integrity
Quality control professionals use sampling in a controlled environment to assess critical parameters such as potency, purity and stability to ensure product quality.
Regular sampling throughout production allows for early detection of deviations from desired specifications, enabling prompt corrective actions.
Contained sampling ensures the integrity of drug products by protecting them from environmental contamination beyond the processing equipment.
By minimising the risk of introducing contaminants at the sampling stage, contained sampling helps achieve regulatory compliance and integrity of the sampling procedure.
With this in mind, strict processing chain protective measures are needed to prevent exposure to the external environment.
2) Ensuring optimum HPAPI containment
HPAPI containment refers to the measures taken to protect workers from exposure to potent compounds such as hormones, steroids or cytotoxic products. The most effective approach to achieve this is keeping these substances contained within manufacturing equipment. Many HPAPIs can be toxic at low doses, which poses a risk to line operatives if they become exposed.
Consequently, ensuring personnel safety and environmental protection is paramount when producing pharmaceuticals containing HPAPIs.
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