Syringe Filling Process
IQ- Filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it
OQ- Syringes are filled with bone void filler to the same level and amount within a range each time (either checked by weight, or if density varies, by volume); Filling range/time must be established for optimal parameters; syringes are free of debris outside of product and do not leak product
PQ- Syringes are identical in filling volume, product, and are within spec for weight, visibility, packaging, and other specs; all raw materials from various venders have been tested on machine and at a production scale successfully

Vascular Graft Weaving Line
IQ- Weaving machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it
OQ- Weaving time and machine parameters are established for optimal performance; Weaves at these parameters should be durable enough to meet specification and standards
PQ- Weaves are identical in size, density and appearance and are within spec for weight, visibility, packaging, and other specs; all raw materials from various venders have been tested on machine and at a production scale successfully

Antibiotic releasing hip stem manufacturing line
IQ- Hip molding machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it; Antibiotic coating machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it
OQ- Hip molding machine has optimal parameters established as well as a range for the temperature, pressure, molding time, molding size, filling amount, curing time, and cooling time.
Antibiotic coating machine has optimal parameters established with a range for temperature, coating amount, coating time, density and temperature of antibiotic, and is reproducible.
PQ- Hips are identical in size, durability, structure, and even coating. The hips are checked for appearance, weight, sterility, defects, deviations, and packaging against the spec. Raw materials are tested from primary, secondary, and any tertiary vendors to ensure that production scale runs successfully.
Wound Healing Growth Factor and delivery device manufacturing line
IQ- Growth factor mixing and filling machine and bottle filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it.
OQ- Growth factor mixing machine has optimal parameters and ranges established including: amounts of each raw material, mixing time, temperature, speed, and cooling time.
Growth factor filling machine has optimal parameters and ranges established including: environmental sterility, filling amount, settling time since creation/mixing, and filling time.
Bottle machine has optimal parameters and ranges established including: air blowing station (to clean out bottle before filling), capping speed, pressure, and torsion.
PQ- Filled bottles are identical in size, volume, color, appearance and weight. The bottles are checked for appearance, weight, sterility, defects, deviations, and packaging against the spec. Raw materials are tested from primary, secondary, and any tertiary vendors to ensure that production scale runs successfully.