Bioreactor: A bioreactor is any device or system that supports a biologically active environment. Most commonly, it is a vessel in which is carried out a chemical process which involves organisms or biochemically active substances derived from such organisms. They are commonly cylindrical, ranging in size from liters to cubic meters, and are often made of stainless steel. Depending upon its normal mode of operation, bioreactors are classified as batch, fed-batch, or continuous.
Things to Consider: Capacity, Gravity flow through design, Self-cleaning tanks, Overflow protection device, Biological oxygenation system, Ability to remove wax or soaps or organic chemicals, Ability to consume hydrocarbons, Electrical requirements, Inlet control options, Inlet fittings and plumbing connections, Discharge options, Drain line control valves, Drain line connections, Biological odor control, Automatic de-foam system, pH controls, Dimensions, Weight, Warranty.
Centrifuge: A motor-driven device that rotates objects around a fixed axis, applying force perpendicular to the axis. Centripetal acceleration separates substances of greater and lesser density. There are many different kinds of centrifuges, some quite specialized. Centrifugation protocols typically specify acceleration to be applied to the sample, rather than specifying a rotational speed. Acceleration is often measured as multiples of g, acceleration due to gravity at the Earth’s surface.
Things to Consider: Speed range (RPM), Maximum relative centrifugal force (RCF), Tube sizes accepted, Total capacity, Fixed or variable speed, Refrigerated option, Refrigerant type, Temperature range, Programmable, Rotor type and capacity, Autoclavable rotor, Timer option, Dimensions, Shipping weight, Electrical requirements, Agency approvals, Warranty.
Biopharmaceutical Coating. Most tablets are coated after being pressed. Tablet coatings must be stable and durable enough to survive handling. They must not cause tablets to stick together during the coating process, and must follow the contours of embossed characters on tablets. Coatings are used for tablets that have an unpleasant taste. A smooth finish makes large tablets easier to swallow. Tablet coatings also extend the shelf-life of tablets that are sensitive to moisture. If a tablet is sensitive to acid, or is irritating to the stomach lining, an enteric coating can be used, which resists stomach acid and dissolves in the high pH of the intestines. Coatings are often chosen to control the rate of dissolution of the drug in the gastro-intestinal tract.
Things to Consider: Palatability, Drug stability enhancement, Tablet mechanical integrity during manufacturing and packaging, friction coefficient, Appearance enhancement, Protection from staining of hands and clothing, Drug release profile modification, Ability to reduce or avoid side effects of drug, Physical separation of incompatible active drug substances during storage of tablets before use, Product identification properties.
Biopharmaceutical Dryers. The most commonly used pharmaceutical dryers are spray dryers. Spray drying is well suited to the continuous production of dry solids in powder, granulate, or agglomerate particle form from liquid feedstocks, which can include solutions, emulsions, and pumpable suspensions. These dryers atomize the feedstock into a spray of droplets, which are put in contact with hot air in a drying chamber. Evaporation of moisture from the droplets and formation of dry particles proceed under controlled temperature and airflow conditions, and powder is continuously discharged from the drying chamber to be recovered from the exhaust gases using a cyclone or a bag filter. Every spray dryer has a feed pump, atomizer, air heater, air disperser, drying chamber, systems for powder recovery, and exhaust air cleaning and process control systems.
Things to Consider: cGMP compliant, Title 21 CFR Part 11 compliant, GAMP 4, Water evaporative capacity (kg/h), Materials in contact with product, Choice of atomizer systems, Ability to dry both aqeous and solvent feedstocks, Configuration suitable for cleaning-in-place, Open or closed cycle operation, Powder discharge method, Explosion protection options, Dimensions, Electrical/fuel requirements, Warranty.
Biopharmaceutical Filing Systems. Generic filing systems provide cabinets, drawers, folders, labels, and other accessories that are needed to ensure that required information can be stored and retrieved on demand, efficiently. In the pharmaceutical industry, the regulatory paperwork associated with research and manufacturing is staggering and requires sophisticated file storage and retrieval operations. The records storage and retrieval operation is responsible for maintaining files for initial new drug applications, INDs, and new drug applications, NDAs. Both paper and computerized pharmaceutical filing systems, based upon years of experience, are specialized to satisfy these requirements.
Things to Consider: Types of documents to be filed, Quantity of documents now and projected, Mobile system type (Mechanical/Electrical/Mechanical with chain box), Carriage color, End panel color, Panel edge type, Shelf color, Wall color, Floor color, Safety features, Floor bearing capacity, Floor area used, Maintenance contract, Warranty.
Granulation. A process which causes powdered particles to adhere permanently to each other to form large particles called granules. There are two methods of granulation: wet, and dry. Wet granulation is the method most extensively used in the pharmaceutical industry. In wet granulation, the aggregation of particles is obtained by using a liquid phase where a binder is homogeneously mixed with the powdered product by kneading the mix. The binder is evaporated from the newly formed granules during a drying step.
Things to Consider: End-point definition, End-point detection method, End-point optimization, End-point reproducibility, End-point scale-up, Power consumption, Specific density, Blade diameter, Blade velocity, Binder amount, Bowl volume, Gravitational constant, Bowl height, Bowl radius, Binder liquid addition rate, Amount of granulating liquid added per unit time, Binder addition time, Particle volume, Wet mass volume, Wet mass, Specific density of particles, Kinematic viscosity, Dynamic viscosity, Torque.
Homogenizer: A piece of laboratory equipment, similar to household blenders, used for homogenizing various materials, such as tissue, plant, food, and soil.
Things to Consider: Variable speed motor speed range, Generator assembly (rotor and stator) size, Power requirements, Viscosity (fine/aqeous/coarse) and volume of media to decide recommended dimensions for shaft and generator assembly, Interchangeability of shafts and generator assemblies, Flow-through chamber option, Agency approvals, Warranty.
Lyophilizers: Equipment used to preserve perishable materials by freeze drying. Freeze drying (lyophilization) is a dehydration process that freezes materials, reduces surrounding pressure, and adds heat to allow frozen water in the material to change from the solid phase to gas.
Things to Consider: Usable shelf area, Ice capacity (kg), Vials capacity, Shelf dimensions, Number of shelves, Shelf spacing, Power requirements, Cooling water flow (Tons of refrigeration per hour), Overall dimensions, Weight, Steam for sterilizing and defrosting, Water-for-injection for cleaning, Compressed air for pneumatic system, Temperature range, Cooling rate, Heating rate, Condenser final temperature, Condenser cooling rate, Final vacuum, Evacuation rate, Leakage rate, Thermal fluid type, Refrigerant type, Warranty.
Biopharmaceutical Tableting. Tableting is the process of forming pharmaceuticals into tablets. The tablet-pressing process requires that all ingredients be dry, powdered, and of uniform grain size. It is critical that the amount of active ingredient is equal in each tablet. Compressed tablets require great pressure to compact the material. If a homogenous mix cannot be obtained with simple mixing, the ingredients must be granulated. Granulation is the process of collecting particles together by creating bonds between them. Two common processes are wet granulation and dry granulation. Wet granulation uses a liquid binder to bond the powder mixture which is subsequently milled to form granules. Dry granulation, which requires a drug with cohesive properties, is conducted on a press, and often requires repeated compaction steps to get the proper result. After granulation the tablets are formed in a tablet press.
Things to Consider: Tablet dimensions, Tablet shape, Tablet mass, Tablet ingredients, Tablet layers, Tablet impressed letters/numbers, Type of machine, Meets GMP requirements, Windows for observing process, Ease of cleaning and maintenance, Controller, Overload protection unit, Gear drive fully enclosed, Number of die sets, Maximum pressure (kN), Maximum diameter of tablet, Maximum depth of fill, Maximum thickness of tablet, Turret speed, Production capacity, Motor power and electrical requirements, Overall dimensions, Net weight, Certifications, Agency approvals.
Biopharmaceutical Vessel Passivation: Vessel Passivation. Passivation is the process of making a material passive or non reactive in relation to another material, prior to using the materials together. The chemicals or coatings used to passivate a vessel are determined by the composition of the vessel material and the composition of the material being processed.
Things to Consider: Quality requirements for specific type of product, Solutions used for passivation (mixed chelant solutions of nontoxic organic acids or viable salt forms applied together with nontoxic synergizing agents), MIL-S-5002C.