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N116 W18515 Morse Dr.
Germantown, WI 53022
Phone: (262) 255-6662 or
1-800-272-3031

Fax: (262) 255-3655
 

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Performance Alloys®

 

 

...World Wide Distributor of Beryllium-Free Copper Alloys...
    Manufacturer of Standard & Custom Components

mold making components, molders, alloys

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mold making components, molders, alloys

PERFORMANCE ALLOYS AND SERVICES, INC.

World Wide Distributor of MoldStar Beryllium-Free Alloys
Manufacturer of Standard & Components

N116 W18515 Morse Drive
Germantown, WI 53022

Phone: (262)255-6662 / (800)272-3031 Fax: (262)255-3655
Web Site: www.moldstar.com E-mail: sales@moldstar.com

Following is a response from the FDA in April 2009 regarding our request “for an update” on the allowance of use of MoldStar150 and MoldStar90 in molding plastic parts for use where there is food or drug contact on the molded parts. 

“The CGMP regulations neither approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the exception of asbestos and fiber-releasing filters, see 211.72). We do not maintain a list of approved equipment. Firms are afforded the flexibility to select equipment that best satisfies their particular needs and that is capable of meeting the relevant CGMP requirements. Each firm is responsible for selecting all equipment used in their manufacturing process to produce quality product in accordance with CGMP.

 The CGMPs require that equipment be of appropriate design to facilitate operations for its intended use and for cleaning and maintenance (see 211.63 and 211.67) and, that any equipment surface in contact with components, in process materials, or drug products not be reactive, additive, or absorptive so as to "alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements" (see 211.65).

 It should be noted that it is a firm’s responsibility to develop and validate test methods capable of detecting contamination in their manufacturing facilities. Persons engaged in the processing, packing, or holding of a drug product for administration to humans or animals are subject to 21 CFR Parts 210 through 226. This generally means that drug product manufacturers must comply with all applicable sections of the regulations including, but not limited to, those sections pertaining to quality control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, and records and reports.”

Diane Raccasi
CSO/Microbiologist
Center for Drug Evaluation & Research, Office of Compliance
Division of Manufacturing & Product Quality
US Food and Drug Administration (FDA)
10903 New Hampshire Ave W051-RM 4355
Silver Spring, MD 20903
(301)796-3927
Diane.Raccasi@fda.hhs.gov

Based on the above response from the FDA, it would appear that as long as the mold components made using either MoldStar150 or MoldStar90 are not damaged where there would be metals left or deposited in the molded parts, there would be no impact or effect on the molded part used for food or drug contact.

 

 
 
                            

 

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While the information contained is deemed reliable, no warranties are expressed or implied. For specific information regarding an application please call 1-800-272-3031 or e-mail us at sales@moldstar.com

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