In response to CGMP of the bio-pharma field, we provide a number of optional functions to support customer needs, reduce obstacles to process development. We can assist in evaluating the appropriate specifications to meet customers' needs and budget.
Biopharmaceutical Manufacturing Equipment (CGMP)
- Material certificates of product contact parts
- Includes a complete document turnover package for validation support including IQ/OQ, material certificate and calibrations.
- Comes with Factory Acceptance Testing (FAT).
- Includes on-site startup assistance, operator and maintenance training, SAT and IQ/OQ execution.
- Optional features refer to User’s requirement specification(URS), such as pressure and temperature monitoring with local display and signal transfer to customer’s data acquisition system upon further request.