Aseptic/ Clean room practices and Process simulation study

We follow comprehensive risk based steps to make complete assessment of your facility for the potential challenges to SAL breach and offer the following collaborative services to your team, manufacturing pharmaceutical, biologics and medical devices – green field and operational:

.   Personal Hygiene and Sanitization; strategy for sterility assurance level;

.   Systematic evaluation of Microbiology and Bio-assay labs from project state to operational stage;

.   Clean room gowning and validation of Bio-load;

.   HEPA, ULPA, LAF, BSC, RaBs, Isolator, platform - material movement inside clean room;

.   Smoke flow pattern, Laminarity and Clean room practices;

.   Dry & Wet heat sterilization, Cleaning cycle validation, Hold-time study;

.   Process simulation study for Liquid, PFS, BFS, DPI and Lyophilized product; training the qualified interventions;

.   Sterility test and Investigation for Sterility failure;

.   Container closure Integrity validation – destructive and non-destructive;

.   Designing and validating product specific BET limit in different dosage forms.