How Do Cleanrooms in The Pharmaceutical And Biotech Industries Ensure Cleanliness?

In many industries, Cleanroom cleanlness plays crucial role in product quality and production safety for different types of products. The following are common ways to ensure Cleanroom cleanliness in major industries:

1. Pharmaceutical industry

Rigorous air filtration systems: Using HEPA or ULPA to remove airborne particles and microorganisms.

Cleanroom Classification: Complies to ISO 14644 set standards to guarantee that Clean Room satisfy stipulated cleanness levels.

Personnel protection: To minimize human contamination staff are expected to wear fresh suits, gloves, mask and shoe covers.

Cleaning and Disinfection: wipe the clean area regularly using sterile cleaners and disinfects as often as possible.

Material Transfer Control: Use Pass Box to pass the materials in order to eliminate external contamination.

2. Biotechnology and Medical industry

Biosafety Cabinets and Laminar Flow Hoods: Used in the handling of delicate biological samples which should not come into contact with other samples.

Positive/Negative Pressure Control: Control the ingress of contaminants into the clean area and prevent leakage of hazardous substances into the clean area by pressurization.

Aseptic operation: Function in a sterilized conditions as a way of producing products that are free from microbes.

Environmental monitoring: Placement of air samplers for monitoring of airborne particles, microbial aerosols, and temperature and humidity to standards.

General Measures

Air flow control: By laminar or turbulent air supply system, make sure the air flow direction is reasonable no to allow pollutants to accumulate.

Personnel training: Train the staff especially the workers frequently to decrease human borne contaminants.

Cleaning procedures: Implement a high standard cleaning policy, namely, basic cleaning and more rigorous cleaning.

Environmental monitoring: Employ sensors and monitorings for measuring particles, temperature & relative humidity and differential pressure in clean area in real time. In the above ways, different industries can ensure the cleanliness of the clean area to ensure the production requirements and quality control indicators.