Flexible containment solutions must work well for every stakeholder. With high potency active pharmaceutical ingredients (HPAPIs) come a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. read how Flow Sciences used a recently developed containment device and augmented to fit the specific needs of the client.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.
Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out.
This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. Additionally, when highly potent active pharma ingredients are not effectively contained, workers may be adversely affected.
When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.
Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.
When Time-Reduction, Cost-Savings, Quality And Reliability Matter, Ropack Pharma Solutions Is The Distribution Partner Positioned To Deliver.
Used 24" Thomas Accela Cota coating pan, model 24-III, stainless steel construction, top vented, serial# 24-320.
One (1) used Vectro granulator, mdoel CF360EX, stainless steel construction, 3-5 kg capacity, xp design with controls, 220 volt, serial# CF-110, new 1982.
Used Vector Hi-Coater coating pan, model VHC-1355, stainless steel construction, with 24" and 30" perforated pans, with spray guns, 460 volt, serial# HCT-392 45938, built 2007.
Used Fuji Paudal Marumerizer spheronizer, model QJ700, stainless steel construction, with 2.0 mm grooved spheronizing plate with plate lift mechanism, jacketed bowl, side discharge with pneumatically operated plug valve, on base, serial 20050, built 1990.
Unused O'Hara LabCoat M5 coating pan, model LCM M5, stainless steel construction with 15" and 12" perforated pans with plenums, spray gun with on board peristaltic pump, Siemens PLC controls with Simatic HMI, .33 hp pan drive, 1/60/240 volt, serial# 4453, built February 2019 and Unused.
Used M5A Fitzmill, stainless steel construction, cantilevered design, fixed bar type hammers, feed hopper, 1.5 hp, 208 volt xp motor, controls with VFD motor controller, controls mounted in Nitrogen Purged panel for XP design, on portable base, serial# 2108.
