Qualification of 100,000 class and 10,000 class Level Clean-Rooms
NEST has multiple clean-rooms that meet ISO14644 Class 7/8 standards. They undergo periodic monitoring
by third parties to ensure compliance with product manufacturing and packaging requirements. Please contact
us through our official website or email to obtain the clean-room qualification testing report.
Methods for Clean-Room Environmental Control
NEST conducts periodic monitoring of dust particles, airborne bacteria, settle plate counts, air exchange rates,
temperature, humidity, pressure differentials, and compressed air in clean-rooms, in accordance with
ISO14644 requirements and company procedures, to ensure compliance with regulatory requirements for
clean-room environments.
Qualification of Sterility Testing Laboratory
NEST has a Biosafety Level 2 (BSL-2) sterility testing laboratory. It conducts testing of the production
environment according to clean-room environmental testing procedures to ensure the safety and reliability of
the production environment, and that the final products meet customer requirements.
Purified Water System Validation
NEST has multiple purified water systems used for cleaning clean-rooms, clean-room garments, and tools,
ensuring the quality of water used in clean-rooms. The company conducts periodic water point testing to test
the properties, acidity/alkalinity, ammonia, conductivity, nitrates, nitrites, oxidizable substances, non-volatile
matter, heavy metals, and microbiological limits of purified water, to ensure compliance with the requirements
of the Chinese Pharmacopoeia (2020 edition) and European Pharmacopoeia(2020) [Purified Water] section.
