Toll manufacturing

Attached is our businesses Technolog Package Request. This information will be helpful m allowing us to meet your needs and expectations by selecting an appropriate toller. Our department developed this list to identify issues to consider m the tolled manufacturing of your product. Any information that you are able to provide will help us considerably and expedite our evaluation process. We look forward to working with you on this opportunity. 

Toll manufacturer Facility that blends, mixes, processes, or packages chemicals. 

Custom and toll manufacturing account for the majority of business between fine-chemical and life science industries. The specialty chemicals industry outside life sciences sources mainly standard products. 

Drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

Waldram, S. P., Toll Manufacturing Rapid Assessment of Reactor Relief Systems for Exothermic Batch Reactions, Hazards XII European Advances in Process Safety, IChemE, Symp., Series No. 134, pp. 525-540, 1994. 

The economic value of food, feed, and biotech pharmaceuticals is enormous. Although fermentation is a key step in the production of these products, it contributes only a small part to the total cost. This is illustrated by antibiotics. The market value of the finished drug is certainly much higher than US 20 billion per year. A toll manufacturer... 

A contract manufacturer is one who supplies manufacturers materials for inventory. This supplier sells products from its inventory to one or more companies for their use or disposition. This type of contractor is sometimes known as an original equipment manufacturer. On the other hand, a toll manufacturer, or toller, is a manufacturer who contracts to ... 

Companies that engage in toll manufacturing can be further classified into three fundamental types. First are companies that have more capacity than they need to produce an established product line. Rather than let that excess capacity stand idle, the companies use it for toll manufacturing to reduce the burden of salaries and overhead attached to the excess capacity while concurrently producing additional income. Pricing for services from these manufacturers are usually quite favorable, since their product line is absorbing their fixed costs. Only variable costs associated with the excess capacity are incurred. 

These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

Toll manufacturer Contract manufacturer (external manufacturer). 

If a company controls all the distribution of a chemical made by another firm, and the company that does the distribution does not process the chemical, then it is a distributor and not a toll manufacturer or processor. 

The regulations place the responsibility for fifing a PMN with the company that orders the toll manufacturing, but does not relieve the company that is actually doing the synthesis from compliance with the PMN rules. 

See also the Chapter 2, TSCA s Scope for a discussion of toll manufacturing. 

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