[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.65]

[Page 119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                          Subpart D--Equipment
 
Sec. 211.65  Equipment construction.

    (a) Equipment shall be constructed so that surfaces that contact 
components, in-process materials, or drug products shall 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.
    (b) Any substances required for operation, such as lubricants or 
coolants, shall not come into contact with components, drug product 
containers, closures, in-process materials, or drug products so as to 
alter the safety, identity, strength, quality, or purity of the drug 
product beyond the official or other established requirements.