Devices Flashcards

Question

What are some drug product dependent attributes for the Ypsomate device?

Answer 1

Delivered Volume Dose Accuracy

Answer 2

Syringe Holder Insertion force (PAR: 30N – 140N2) / position (PAR: ≤11.38mm) Drive Unit Insertion force (PAR: CP07: 30N – 150N2, CP20: 30N – 185N2) / position (PAR: 69.4mm – 70.1mm3) Syringe Insertion Force (PAR: ≤24.9N2) Syringe RNS Displacement (PAR: ≤1.5 mm2)

Answer 3

-Incoming stopper trim edge exceeding upper trim edge diameter - Increased Delivery time -RNS gap (displacement) - could impact CCI -Incorrect components on line HSS where NSS was required NSS where HSS is required HSS where placebo is required Line clearance failure = increased / decreased delivery time -Syringe and Force Syringe insertion force Syringe holder insertion force Syringe holder position Drive unit insertion force Drive unit insertion position

Answer 4

Assembly performed on only CP07 for Beli only It has been modified for lupus patients - for dexterity and grip

Answer 5

Primary container - Syringe and stopper (pre-filled syringe) Stopper - rubber with Fluorotic coating Autoinjector device components: PowerPack Subassembly Body Cap (inner body) Subassembly Outer Body Subassembly

Answer 6

The syringe housing holds the syringe by the shoulder RNS has to pass though holder The bottom of holder has a gap to allow flex (C clip) Removal of cap will also remove the RNS of the syringe Needle cover sits on skin and slides as device is pushed down Legs of needle cover activate the power pack Once actuation is complete legs are locked into place preventing movement of cover Protecting against needle stick injuries

Answer 7

This is a spring loaded component The plunger rod and the plunger rod spring are components within this Power Pack

Answer 8

1. Insertion of the pre-filled syringe into the body-cap sub-assembly This is a two stage process involving first insertion of syringe into syringe holder followed by seating of syringe/syringe holder to bottom of the body-cap sub-assembly 2. Insertion (assembly) of the power pack onto the body-cap sub-assembly 3. Assembly of the outer body onto the body-cap sub-assembly

Answer 9

All 3 device components (body cap subassembly, powerpack, and outer body) are loaded into the machine in component trays as supplied by SHL. Tubs of prefilled syringe are manually loaded onto a conveyor feed system Sensors and vision systems check the all components for certain characteristics/conditions 100% components are checked, if anything doesn't satisfy (assembly positions/distances and forces/torques) they will be automatically rejected Controlled and monitored using position sensors and force via LinMot technology and load cells

Answer 10

A functional test (delivered volume and needle guard lockout)

Answer 11

Needle Extension Needle guard lockout Force to overcome lockout Needle safe distance Delivery volume Delivery time

Answer 12

Syringe insertion force (PAR: 6N-50N) Position of the needle shield (RNS) on the prefilled syringe (PAR: ≤1.5mm) Power pack insertion position (PAR: 162.2 +/-0.5mm) Power pack orientation (PAR: 107.07mm)

Answer 13

RNS displacement Colour band inspection Syringe is inserted into device while monitoring force and distance Power Pack is inserted into the AI Body & Cap while monitoring distance Power Pack is orientated into the AI Body & Cap while monitoring force and distance

Answer 14

2D barcode is directly applied to the device to identify it. This is checked by vision system Syringes are banded on CP08 inspection line During assembly if the coloured band does not match the product, then the syringe is rejected All packaging and labeling is applied on CP21 packaging line

Answer 15

Presence of all components Transit clip for SSD and syringe holder position of Molly checked * Angle of RNS determined * Torque applied to plunger rod insertion monitored Gap between plunger rod and stopper measured * Gap between RNS and shoulder measured * Colour banding on syringe check * Force required to insert syringe and final distance obtained Force required to assemble SSD body into flange and final distance obtained Force required to assembly Molly Power pack and final distance obtained (CP07 only) Force required to assembly Molly Outer body and final distance obtained (CP07 only) Force required to insert syringe holder in Ypsomate device and final distance obtained Force required to insert Ypsomate Drive unit and final distance obtained 2D barcode on assembled device verified * Reject confirmation

Answer 16

Historical issue in the Molly devices The point where the syringe is pushed past the retention features deeper into the device are where the insertion reject rate occurs For a bad assembly the c-clip re-opens prior to entering the seat, resulting in a collision between the c-clip and seat and a rejected device

Answer 17

There was a correlation between the cap remover internal diameter and the number of device rejects Turns out the diameter had changed over time therefore 7.20 mm caused a lot of rejects whereas 7.60 mm (implemented request for this diameter) resulted in very few The larger diameter required less force to push the RNS into the cap remover, as the compression on the syringe is lower Reducing the risk of insert overload / c-clip jam reject

Answer 18

Syringe batches were also though to play a role Silicone had an influence on the performance of a syringe batch Reject rate can therefore be predicted as each batch is tested for this - we can prioritise batches that will result in a lower reject by correlation

Devices Flashcards

(42 cards)