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.
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.
Understanding and being able to control granulation is essential to the production of high quality pharmaceuticals. Fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size therefore affording superior process reproducibility and better process control than many other granulation techniques.
The enhanced precision used in 3D printing can drive efficiencies in early drug development by allowing more flexibility with dosage size and strengths, leading to a more effective use of costly resources.
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.
Used Frewitt hammer mill mounted in isolator, model MFH-6, stainless steel construction, nominally rated 2000 kg/hr, gravity feed, service door mounted in 2 glove isolator on cart, Frewitt serial# 5078510125.
Used 150 cu ft Patterson Kelley double cone blender, 316L stainless steel product contact surfaces, approximately 95" diameter, rated 62#/cu ft maximum material density, on stainless steel stands with 20 hp motor drive giving approximately 1.4 - 8.6 rpm shell rotation speed, 18" feed opening, 10" discharge opening, on 304 stainless steel stands with approximately 25" discharge height, approximately 144" overall installed height, approximately 124" swing radius, serial# BC65251, built 2013.
Used Fette rotary tablet press, model PT3090, 61 station, keyed upper punch guides, 100 KN main compression, 100 KN pre compression, dual sided with force feeders, 16 mm max tablet diameter, 18 mm max depth of fill, rated up to 585,500 tablets/hour, removable turret, stand alone IC control panel, serial# 29-383, built 2002.
Used 75 cu ft Patterson Kelley twin shell blender, 316 stainless steel construction, rated 60#/cu ft maximum material density, with high speed bar driven by 10 hp, 230/460 volt motor, 10 hp, 460 volt shell motor with electric brake, on stainless steel stands with 73" stand extensions, serial# C425287, built 1998.
Unused GEA Niro fluid bed processor, model MP7, stainless steel construction, 8480 total volume, 1350 liter bowl capacity, 12 bar shock rating, Munters air handling system, 100 hp Illinois Blower, product bowls, stainless steel cyclone, with controls, GEA project# 13350.1320, built 2014. Photo is representative.
