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Biotechnology and Pharmaceutical Manufacturing Services Specifications

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Services Offered




   Services Offered       
   Your choices are...
 
      
 
   Analytical Testing / Validation
 
     Inspection services and/or analytical testing of processed materials, chemicals, or other products.
 
   Nanoparticle / Powder Processing
 
     Powder processing services on the bulk solid or granule, micron, or nanoparticle scale.
 
   Process Optimization / Development
 
     Process development or optimization services.
 
   Technology and Licensing
 
     Technology and licensing develop, license, or sell specialized process technologies.
 
   Training / Consulting
 
     Training or consulting services for fluid processing systems is provided.
 
   Trial Facility Leasing / Tolling
 
     Trial facility leasing provides contractual access to trial facility, so that customers can evaluate or prove processes or process equipment before making major capital expenditures. Facilities may be on-site or in-house. Contracts typically include rental fees, lease terms, transportation costs, cleaning, etc.
 
   Research and Development
 
     Research and development for new processes, process technologies, lower cost processes, or alternate processing steps.
 
   Warehousing / Distribution
 
     Warehousing, distribution, sourcing, and other logistics services are provided.
 
   Specialty / Other
 
     Other specialized, proprietary or unlisted processing services.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
Processing Capability




   Processes:       
   Your choices are...
 
      
 
   Acylation / Alkylation (e.g., Friedel-Crafts)
 
     Acylation synthesis produces deactivated monoacylates through an electrophilic, aromatic substitution reaction between arenes and acyl chlorides or anhydrides. In the Friedel-Crafts alkylation processes, the electrophilic aromatic substitution is catalyzed by a Lewis-acid and produces alkylated products through the reaction of arenes with alkyl halides or alkenes. Alkyl groups can activate arene, resulting in polyalkylated products. Typically, Friedel-Crafts reactions for alkylation or acylation of aromatic compounds are catalyzed by aluminum chloride or other Lewis acids.
 
   Atomization / Powder Production
 
     Powders are produced through an atomization, spray drying, milling, precipitation, or other proprietary process.
 
   Blending / Mixing
 
     Mixers or blenders are driven by a shaft, speed reducer, or electric motor.
 
   Coating
 
     Bulk materials such as powders, granules, or continuous webs are coated.
 
   Compounding
 
     Compounding mixes or blends and/or reacts all of the ingredients required to produce a finished product. For example, a compounded plastic resin or elastomer compound typically consists of base polymer resin(s), chemical additives, and reinforcing or extending fillers. Compounding can be used for plastics, rubber, elastomers, cleaning agents, lubricants, greases, masterbatch colorants (pigments, dyes), additive masterbatches, organic chemicals, chemical additives, metal working fluids, oils, oil and fuel additives, fuel mixtures, and other materials. 
 
   Conversion / Forming
 
     Conversion processes compact, form, cut or otherwise converts materials into different shapes or forms.
 
   Crystallization
 
     Crystallization cools a liquid solution or evaporates a solvent in order to form solid, solute crystals. As they leave the crystallizer, the slurry crystals are often forced through a circulation evaporator and may subsequently be separated from the liquid in a filter or centrifuge.
 
   Distillation
 
     Distillation applies and removes heat in order to separate a liquid or vapor mixture of two or more substances into component fractions of a desired purity. Chemicals and conditions determine which distillation processes can be used. Examples include no-pressure distillation, vacuum distillation, steam distillation, molecular distillation, and thin film distillation.
 
   Drying / Freeze Drying
 
     Drying uses evaporation, sublimation, or freeze-drying processes to remove liquids or moisture from bulk solids, powders, parts, continuous sheets or other liquids.
 
   Esterification
 
     In the Fischer-Speier esterification method, esterification of acids occurs by refluxing with excess alcohol in the presence of hydrogen chloride or other acid catalysts.

 
 
   Evaporation
 
     Evaporation is thermal separation or thermal concentration process that removes liquid from a solution, suspension, or emulsion by boiling.
 
   Fermentation / Biotransformations
 
     Fermentation is used in the production of drugs, foodstuffs and beverages. The process uses fermentation, biological catalysts or enzymatic compounds, microrganisms, and other biological agents or biotransformations to process or synthesize products. Enzymes are very effective at breaking down certain proteins. Composting is a biotransformation process that uses bacteria to break down organic waste.
 
   Filtration / Extraction
 
     Molecular sieve filtration often uses a porous molecular structure that selectively adsorbs or rejects molecules based on differences in molecular size or shape.
 
   Formulation
 
     Formulas are developed for chemical, polymer, or material intensive products. Formulas provide ingredients, amounts, and processing instructions.
 
   Granulation / Agglomeration
 
     Granulation, pelletization, briquetting or agglomerations are size enlargement processes. Granulation or agglomeration increases particle size by adhering or bonding together several fine particles with a liquid or wax binder to from larger agglomerates. Pelletization or briquetting compacts fine powders into larger pellets or briquettes.
 
   Halogenation (e.g., Fluorination / Chlorination)
 
     Halogenation is the reaction, chemical combination or exposure of water or other chemicals to fluorine, chlorine, bromine, iodine or other halogens. Exposing water to chlorine can destroy biological contaminants. Halogenation processes include fluorination, chlorination, bromination, electrolytic fluorination and iodination as well as related processes such as iodine recovery.
 
   Hydroformylation / Formylation
 
     Hydroformylation or formylation reactions such as Duff, Gattermann-Koch or Vilsmeier-Haack are performed. In Duff reactions, the formylation of phenols or aromatic amines with hexamethylenetetramine uses an acidic catalyst. Gattermann-Koch reactions are catalyzed by using aluminum chloride at high-pressure in order to achieve the formylation of benzene, alkylbenzenes or polycyclic aromatic hydrocarbons with carbon monoxide and hydrogen chloride. Formylation of the amino acids in proteins is a naturally occurring process. 
 
   Hydrogenation
 
     Hydrogenation is the reaction of hydrogen with another chemical or raw material. For example, Sorbital is formed through the hydrogenation of corn syrup. Formylation of the amino acids in proteins is a naturally occurring process. 

 

Fischer Tropsch (gas to liquids) or linear alpha olefin hydroformylation processes are used in the production of synthetic oils fluids. In the Fischer Tropsch reaction or Synthol process, hydrocarbons, aliphatic alcohols, aldehydes, and ketones are synthesized by the catalytic hydrogenation of carbon monoxide using synthesis gas enriched from the passage of steam over heated coke. 

 

The Bergius reaction is used to synthesize petroleum-like hydrocarbons by the hydrogenation of coal at high temperatures and pressures (~ 450°C @ 300 atm) with or without catalysts.
 
   Milling / Size Reduction
 
     Milling, ball milling, crushing, shredding, granulating, pulverizing, or other services are offered in order to reduce coarse, bulk solids into finer granules or powders.
 
   Organometallic / Grignard Reactions
 
     Processing or expertise in using organometallic or Grignard reactions is available. Originally, Grignard reactions were the addition of organomagnesium compounds or Grignard reagents to carbonyl compounds to generate alcohols. The reaction scope now includes the addition of Grignard reagents to a wide variety of electrophilic substrates.
 
   Oxidation Reactions
 
     Chemicals or materials with an oxidation reaction such as epoxidation are processed.
 
   Packaging / Microencapsulation
 
     Packaging is used for chemicals, pharmaceuticals or bulk materials such as powders, granules, liquids or continuous webs. Alternatively, packaging also provides encapsulation, microencapsulation, tableting, blister packaging or drug delivery systems for powdered or liquid drugs, vitamins or other substances.
 
   Polymerization
 
     Condensation, addition, or other reactions are used to polymerize or copolymerize monomers or intermediates into longer chain molecules.
 
   Recovery / Extraction
 
     Extraction or recovery of valuable or reusable components from a waste stream or scrap material.
 
   Reduction Reactions
 
     A reduction reaction to process chemicals or materials is used.
 
   Refining / Purification
 
     Refining or purification services.
 
   Sterilization / Disinfection
 
     Sterilization or disinfecting of chemicals, materials, surfaces or environmental media (water, soil, etc.) kills or destroys any microbial contamination (mold, bacteria, viruses, protozoa, etc.).
 
   Synthesis
 
     Reactions to synthesize chemicals or materials are performed.
 
   Treatment / Decontamination
 
     Treatment or decontamination of liquids, oils, colloids, dispersions, water, soil, building materials, waste, scrap, powders, granules or other bulk materials.
 
   UV / Photochemical
 
     Ultraviolet (UV) light exposure is used to degrade, breakdown, sterilize certain compounds or chemicals. UV light or radiation sources are used to initiate reactions or cure certain polymers and resins.
 
   Other
 
     Other unlisted processes or reactions.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
   Clean in Place?
 
     Facilities use clean-in-place (CIP) equipment that can be cleaned without disassembly. Typically, a spray device is used for cleaning.
 
   Search Logic:      "Required" and "Must Not Have" criteria limit returned matches as specified. Products with optional attributes will be returned for either choice.
   Clean Room?
 
     Facilities locate sterilization and/or manufacturing equipment in a clean room in order to eliminate or minimize the contamination of processed materials, chemicals or products.
 
   Search Logic:      "Required" and "Must Not Have" criteria limit returned matches as specified. Products with optional attributes will be returned for either choice.
   Cryogenic Processing?
 
     Chemicals or materials are processed at very low or cryogenic temperatures. 
 
   Search Logic:      "Required" and "Must Not Have" criteria limit returned matches as specified. Products with optional attributes will be returned for either choice.
   Vacuum Processing?
 
     Vacuum processing of chemicals or materials is provided.
 
   Search Logic:      "Required" and "Must Not Have" criteria limit returned matches as specified. Products with optional attributes will be returned for either choice.
Products Processed




   Form:       
   Your choices are...
 
      
 
   Bulk Solids / Granules
 
     Bulk solids or granules are processed.
 
   Gas / Liquid Gas
 
     Processing or synthesizing of industrial gases or liquid gases such as argon, nitrogen, oxygen, methane, acetylene, propane or other gas mixtures.
 
   Liquids
 
     Processing of liquids.
 
   Nanomaterials / Nanoparticles
 
     Nanomaterials consist of particles with an average size of less than 100 nm.
 
   Powders
 
     Powders are finely divided or powdered metals, ceramics, polymers, composites, minerals or other raw materials.
 
   Webs / Continuous Stock
 
     Processing of continuous webs or continuous stock.
 
   Other
 
     Other unlisted forms.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
   Chemicals / Chemical Products:       
   Your choices are...
 
      
 
   Acetylenes
 
     Processing or synthesizing of acetylenes.
 
   Alcohols
 
     Processing or synthesizing alcohols.
 
   Biochemicals / APIs
 
     Processing, reacting, extracting or synthesizing of biochemicals such as proteins, peptides, amino acids, amino acid analogs, DNA, RNA, steroids, carbohydrates, oligonucleotides, lipids, animal fats, vegetable oils, waxes, sterols, triglycerides, other biological or botanical derivatives, active pharmaceutical ingredients (APIs) or high potency actives (HPAs). 
 
   Catalysts / Initiators
 
     Processing or synthesizing of catalysts or initiators.
 
   Chemical Agents / Additives
 
     Processing or synthesizing chemical agents or additives such as stabilizers, plasticizers, flame retardants, release agents, etc.
 
   Cleaners / Surface Active Agents
 
     Processing or producing of cleaning and surface active agents such as cleaners, detergents, surfactants, emulsifiers, flocculants, dispersing agents, settling agents, and soaps (saponification end products).
 
   Cosmetics / Soaps
 
     Fluid processing systems are to process cosmetics such as algae extracts, bee’s wax, brown moss extracts, flower extracts, lanolin alcohols, root extracts, wool fatty acids, wool alcohols, and volatile oils and scents.
 
   Filler / Extenders
 
     Synthesizing or processing of fillers or extenders.
 
   Foods / Beverages
 
     Synthesizing or processing of foods and beverages such as aroma concentrates, butter, capsicum, coffee, cacao biocatalyst concentrates, diglycerides, dimeric fatty acids, fatty acids and derivatives, fish oils, fruit juices, milk products, mono-glycerides, palm oils, protein and protein substances, rice bran oils, soybean oil, seed oils, sugar derivatives, tea, and tocopherols.
 
   Inorganic Chemicals
 
     Synthesizing or processing of inorganic chemicals.
 
   Lubricants / Greases
 
     Synthesizing or processing of lubricants or greases.
 
   Monomers and Intermediates
 
     Synthesizing or processing of monomers and intermediates.
 
   Organic Chemicals
 
     Synthesizing or processing of organic chemicals such as alcohols, alfol esters, detergents, fertilizers, glycol ethers, herbicides, halogenated hydrocarbons, insecticides, organometallic compounds, silicone oils, tall oils, turpentine, and waxes.
 
   Pharmaceuticals / Drugs
 
     Synthesizing or processing of pharmaceuticals or drugs, a category that includes vitamins, amino-acid esters, antibiotics, beta-carotene, ferments, glucose derivatives, hormones, antioxidants, and indoles.
 
   Pigments / Dyes
 
     Synthesizing or processing of pigments, dyes or other colorants.
 
   Polymers
 
     Synthesizing or processing of polymers.
 
   Reagents
 
     Synthesizing or processing of reagents.
 
   Solvents
 
     Synthesizing or processing of solvents.
 
   Specialty / Other
 
     Other unlisted products.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
   Materials / Material Products:       
   Your choices are...
 
      
 
   Textiles
 
     Synthesizing or processing of textile materials.
 
   Adhesives / Sealants
 
     Synthesizing or processing of adhesives and sealants.
 
   Carbon / Graphite
 
     Synthesizing or processing of carbon or graphite materials.
 
   Ceramics
 
     Synthesizing or processing of ceramics.
 
   Coatings / Paint
 
     Synthesizing or processing of coatings or paint.
 
   Cobalt / Cobalt Alloy
 
     Cobalt and cobalt alloys are non-ferrous magnetic alloys with high strength and toughness, excellent corrosion and oxidation resistance, and high temperature strength. Cobalt can also be magnetized. Cobalt's properties result in the use of cobalt alloys in jet engine super-alloy components, prosthetic devices, magnets, and cutting tool binders. Cobalt is a useful alloying element in tool, maraging and other alloy steels.
 
   Elastomers / Rubber
 
     Synthesizing or processing of elastomers or rubber.
 
   Noble / Precious Metal
 
     Noble and precious metal alloys such as silver, gold, platinum and palladium alloys are extremely resistance to corrosion and oxidation. Noble and precious metal alloys are used in electrical contacts, electronic connectors, chemical process components, catalysts, jewelry and other specialized applications.
 
   Plastics
 
     Synthesizing or processing of plastics such as epoxy resins, isocyanates, polyesters, and polyethers.
 
   Stainless Steel
 
     Stainless steels are highly corrosion resistant, ferrous alloys that contain chromium and/or nickel additions. There are three basic types of products: austenitic stainless steels, ferritic and martensitic stainless steels, and specialty stainless steels and iron superalloys.

Austenitic stainless steels (AISI 300 / 200 Series) are highly corrosion resistant, ferrous alloys that contain chromium and nickel or manganese additions. Generally, austenitic stainless steels are more corrosion resistant than ferritic or martensitic stainless steels. Annealed austenitic stainless steels are non-magnetic. Cold working is used to harden austenitic stainless steels because these alloys do not respond to conventional quench and temper hardening processes.

Ferritic and martensitic stainless steels are highly corrosion resistant, ferrous alloys that contain chromium and/or carbon additions. Ferritic stainless steels are soft, easy to form metal alloys. Cold working is used to harden ferritic stainless steels because these alloys do not respond to conventional quench and temper hardening processes. Ferritic stainless steels are formed to fabricate mufflers and other sheet metal components that require good corrosion resistance. Martensitic stainless steels can be hardened by a conventional quench and temper operation. Martensitic stainless steels are used for knife blades, tooling or other applications that require good corrosion resistance combined with higher hardness and wear resistance.

Specialty stainless steels and iron superalloys are highly corrosion resistant, ferrous alloys containing chromium, nickel or other alloying additions to provide high strength or heat resistance. Duplex and precipitation hardening stainless steels belong in this category.
 
   Titanium / Titanium Alloy
 
     Titanium and titanium alloys are non-ferrous metals with excellent corrosion resistance, good fatigue properties, and a high strength-to-weight ratio. Titanium's properties result in the use of titanium and titanium alloys in aircraft or air frame parts, jet engine super-alloy components, corrosion resistant chemical process equipment (valves, piping, and pumps), prostheses or medical devices, and marine equipment.
 
   Specialty / Exotic Alloy
 
     Other unlisted, specialty or proprietary metals or alloy grades. These materials are based on a unique composition or alloy system, use a novel processing technology, or have properties designed for specific applications.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
Processing Capacity




   Run / Batch Size:       
   Your choices are...
 
      
 
   Laboratory / Benchtop Scale
 
     Typically, laboratory or benchtop scale means that processing capacity does not exceed a few pounds or a few gallons. Actual quantities vary based on the type of material. For example, laboratory scale quantities may be expressed in milligrams for nanomaterials and specialized biochemical compounds. Usually, one person can easily and safely operate laboratory scale equipment. This category excludes facilities whose function is to produce commercial quantities.
 
   Pilot Scale
 
     Pilot scale is a small-scale production process that is larger than laboratory scale and used to develop a subsequent full-scale process. Typically, pilot scale quantities are in the range of several drums (e.g., 55-gallon drums) or hundreds of pounds or gallons; however, quantities vary with the density and type of processed material, chemical or product. Pilot scale facilities are better than laboratory scale facilities at simulating production processes and can be used for troubleshooting, improving and optimizing processes.
 
   Production Lots / Field Scale
 
     Companies may have commercial, production, field or industrial scale processing facilities. Typically, the processing ranges are in thousands of gallons or pounds; however, quantities vary by material, chemical, or product.
 
   Other
 
     Other process scales.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
   Capacity (Volume Basis):
 
     Enter the the volume to process or synthesize.
 
   Search Logic:      User may specify either, both, or neither of the "At Least" and "No More Than" values. Products returned as matches will meet all specified criteria.
   Capacity (Mass Basis):
 
     Enter the mass or weight capacity to process or synthesize.
 
   Search Logic:      User may specify either, both, or neither of the "At Least" and "No More Than" values. Products returned as matches will meet all specified criteria.
Certifications / Quality Requirements




   Certifications / Quality Requirements       
   Your choices are...
 
      
 
   AS 9100
 
     AS 9001 is a set of quality guidelines and requirements published by the Society of Automotive Engineers (SAE) in cooperation with major aerospace manufacturers. AS 9001 is based on ISO 9001 but maintains a particular focus on the aerospace industry.
 
   cGMP Compliant
 
     Companies comply with current good manufacturing practices (cGMP).
 
   DOT
 
     Supplier is permitted by the U.S. Department of Transportation to ship or transport specific class (solid, hazardous, medical, etc.) waste or scrap materials. 
 
   EPA
 
     Supplier is permitted by the EPA for specific recycling or reclamation activities or processes wasters in full compliance with standards, guidelines and methods set forth by the Environmental Protection Agency (EPA).
 
   FDA Registered
 
     Company laboratories are accredited or accepted by the U.S. Food and Drug Administration (FDA).
 
   ISO
 
     Companies comply with International Standards Organization (ISO) standards. Examples include ISO 7779, ISO 9000, ISO 9001, ISO 9002, ISO 13485, ISO 14000 and ISO 17025. ISO 7779 covers acoustics and the measurement of airborne noise emitted by information technology (IT) and telecommunications equipment. ISO 9000 establishes standards for quality management. ISO 9002, a certification that has been superseded by ISO 9001:2000, is dedicated to continuous improvement. ISO 13485 covers medical devices, quality management systems and requirements for regulatory purposes. ISO 14000 establishes standards for environmental management, a term that describes a company’s efforts to minimize its harmful effects on the environment and improve its environmental performance. ISO 17025 outlines general requirements for the competence of testing and calibration laboratories.
 
   ISO 9001:2000
 
     ISO 9001:2000 establishes requirements for company quality management systems. Standards range from manufacturing to services such as design, development, production, and installation.
 
   ISO 14001
 
     ISO 14000 provides an internationally recognized framework for environmental management, measurement, evaluation and auditing. It does not prescribe environmental performance targets, but instead provides organizations with tools for assessing and controlling the impact of activities, products or services on the environment. These standards are designed to be flexible enough to be used by any organization of any size and in any field. They address the following subjects: environmental management systems, environmental auditing, environmental labels and declarations, environmental performance evaluation, and life cycle assessment.
 
   Other
 
     Other unlisted, specialized, or proprietary certification or standard.
 
   Search Logic:      All products with ANY of the selected attributes will be returned as matches. Leaving all boxes unchecked will not limit the search criteria for this question; products with all attribute options will be returned as matches.
Regional Preference




           
   Your choices are...
 
      
 
   North America
 
     Companies are located in the United States, Canada or Mexico.
 
   United States Only
 
     Companies are located in the United States.
 
   Northeast US Only
 
     Companies are located in the Northeast United States, namely Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont.
 
   Southern US Only
 
     Companies are located in the Southern United States, namely Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington D.C., and West Virginia.
 
   Southwest US Only
 
     Companies are located in the Southwest United States, namely Arizona, California, Colorado, Nevada, New Mexico and Utah.
 
   Northwest US Only
 
     Companies are located in the Northwest United States, namely Idaho, Montana, Oregon, Washington and Wyoming.
 
   Midwest US Only
 
     Companies are located in the Midwest United States, namely Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Nebraska, North Dakota, Ohio, South Dakota and Wisconsin.
 
   Canada Only
 
     Companies are located in Canada.
 
   South / Central America Only
 
     Companies have facilities in South American countries such as Argentina, Brazil, or Chile; or in Central American countries such as Costa Rica, Honduras, Panama, etc.
 
   Europe Only
 
     Companies are located in Europe, namely Germany, Ireland, Italy, United Kingdom, etc.
 
   South Asia Only
 
     Companies are located in South Asia, namely India, Pakistan, Nepal, etc.
 
   Near East Only
 
     Companies are located in the Near East, namely Egypt, Israel, Saudi Arabia, etc.
 
   East Asia / Pacific Only
 
     Companies are located in East Asia, namely China, Japan, Taiwan, etc.
 
   Other
 
     Other unlisted country or region.
 
   Search Logic:      Products with the selected attribute will be returned as matches. Leaving or selecting "No Preference" will not limit the search criteria for this question; products with all attribute options will be returned as matches.
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