Craftsman Bio Process case studies
Craftsman Bio Process · Put your knowledge to work in context.
The ASME Bioprocessing Equipment (BPE) Certification is a conformity assessment program that certifies the quality management system of organizations manufacturing tubing and fittings for bioprocessing service. It is aimed at manufacturers whose products must demonstrate conformity to the ASME BPE Standard, and it is administered through ASME's Conformity Assessment function rather than as a traditional written examination. The Craftsman Bio Process case studies are 5 cases and about 3,529 words.
1Phosphate Buffer pH and Conductivity Excursion Before Inoculation
During preparation of 2,000 L of 20 mM phosphate buffer for a 500 L perfusion bioreactor, the operator dissolves sodium phosphate salts in WFI at 9°C. The batch record requires pH 7.20 ± 0.05 and conductivity 12.5 ± 0.5 mS/cm at 25°C.
588 words, about 3 min2Seed Train Inoculation Density Shortfall and Schedule Pressure
At the 50 L seed bioreactor stage, the working volume is 40 L and the target inoculation density is 0.60 × 10^6 viable cells/mL. The available seed culture contains 2.4 × 10^6 viable cells/mL at 88% viability in a 5 L bag with 4.8 L.
748 words, about 4 min3Out-of-Specification Titer and Purity After Sample Stagnation
At day 12 of a 2,000 L fed-batch CHO culture, the in-process titer by Protein A HPLC is 2.1 g/L against a historical range of 3.0–3.5 g/L. The sample was drawn from a sample valve after 45 minutes without flushing and held 24 hours at 2–8°C before analysis.
801 words, about 4 min4New Single-Use Bag Film Lot and Operator Training Gap
A contract manufacturing organization is preparing to run a 1,000 L single-use bioreactor campaign in five days. The supplier has changed the film lot for the 1,000 L bag.
705 words, about 4 min5Protein A Resin Cycling Beyond Cleaning Verification Limit
After 95 cycles on a Protein A chromatography column, the eluate turbidity is 12 NTU against an action limit of 5 NTU, and the column pressure drop has risen from 0.4 to 0.8 bar at the same flow rate. The validated resin lifetime is 100 cycles.
687 words, about 3 min