This equipment is used to increase shelf life of the product by removing water, accommodate downstream processing, extend shelf life and provide product stability.
What is lyophilizer?
100
These serotypes are conjugated in an aqeous solution.
What is 4, 9V, 14 and 18C?
100
This is the target dilution concentration when adding WFI to the 80L reactor vessel.
What is 2g/L?
100
This is the system that samples are entered into so that an audit trail may be captured, and sample data can be recorded.
What is LIMS?
200
This procesdure takes approximately 30 minutes and consists only of a WFI rinse.
What is a standard CIP?
200
There are two forms of conjugation
What is Aqueous and DMSO?
200
These serotypes: 6B, 19A, 19F and 23F utilize this as a reconstitution buffer?
What is DMSO?
200
If the activation solution is too acidic, this is added.
What is Sodium Phosphate?
200
This system allows us to view inventory, check transactions and to locate the storage location of materials.
What is SAP?
300
These consist of all transfer lines, and are grouped according to process circuits. There are 5.
What is a Super Circuit?
300
This serotype utilizes the cHap column, while this serotype utilizes the DEAE.
What is Type 4 and 23F?
300
When DMSO is used in a batch, the dissolution occurs in this.
What is the glove box?
300
If the activation solution is too basic, this is added.
What is Hydrochloric acid?
300
This system allows us to view elctronic batch records.
What is MES?
400
During the Chrom Process, these buffers are utilized in this order.
What is Buffer 4,3,5 and 6?
400
These are the two main steps in the Chemistry process.
What is Activation and Conjugation?
400
This stops the linking process and closes off any open sites on the carrier protein.
What is capping?
400
These are the three most important factors to consider during the activation.
What is Temperature, Time and Concentration?
400
This system allows us to write work orders.
What is EAMS?
500
This is performed once a vessel has been opened after maintenance has been performed. This procedure has three phases: acid wash, caustic wash and rinse and has a three month expiry
What is a maintenance CIP?
500
List the Lyo phases in the order that they occur.
What is CIP, SIP, Leak Test, Ram Bellows, Freez Dry Auto Cycle, and Defrost?
500
During the Ultrafiltration/Diafiltration, everything goes to waste, except this.
What is the Retentate?
500
Partial Depyruvylation is utilized on this serotype to remove 20% of pyruvates that would otherwise interfere with the oxidation step.
What is Serotype 4?
500
This is where we record safety concerns, or near misses.