The negative pressure weighing chamber is a core specialized equipment in the raw material weighing and batching processes of pharmaceutical factories. Its functions revolve around three core demands: personnel safety, material purity, and environmental cleanliness. It is a key facility to ensure the compliance of drug production and product quality. Its specific functions are as follows:
When the negative pressure weighing chamber is in operation, it maintains a negative pressure relative to the outside inside, and the airflow will flow unidirectionally from the outside to the inside to ensure the safety of the operators. When operators weigh and repackage highly active, toxic and allergenic active pharmaceutical ingredients, this air flow organization can effectively prevent harmful substances such as dust and aerosols from leaking into the production workshop, avoid inhalation or skin contact by operators, and reduce occupational health risks.
The negative pressure weighing chamber is equipped with a high-efficiency filtration system (HEPA/ULPA) to ensure the purity of materials and the quality of drugs. The air entering the chamber is strictly filtered to remove particles, microorganisms and other pollutants in the air. On the one hand, it prevents external impurities from contaminating the active pharmaceutical ingredients in the weighing process and avoids cross-contamination of materials. On the other hand, unidirectional negative pressure airflow can prevent the diffusion of dust from different batches and types of raw materials, ensuring the accuracy of ingredient preparation and the accuracy of drug components, and meeting the cleanliness requirements for material handling stipulated in GMP (Good Manufacturing Practice for Pharmaceuticals).
Pharmaceutical factory production workshops (especially clean areas) have strict standards for the content of environmental particles and microorganisms to maintain the cleanliness of the production environment. The negative pressure weighing chamber collects the dust generated during the weighing process through an internal dust removal system. At the same time, it uses negative pressure to prevent the dust from escaping, avoiding contamination of the overall environment of the clean area and ensuring the environmental compliance of subsequent processes such as formulation and filling.
Both domestic and international regulations related to the production of pharmaceuticals (such as China’s GMP, the US FDA and cGMP) have clear stipulations on the handling facilities for high-risk materials. The configuration and use of negative pressure weighing rooms are necessary conditions for pharmaceutical factories to obtain the qualification certification for drug production and ensure that the production process complies with regulatory requirements.