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Title: Section 70-3.4 - Record keeping

Effective Date


70-3.4 Record keeping.

(a) Each facility shall retain for three (3) years records of: validation testing and challenge testing, including protocols and test results; routine system’s monitoring; and, where applicable, Department approval as an alternative treatment technology.

(b) Each facility shall document each employee’s participation in training and/or retraining in autoclave operations, and shall retain such records for three (3) years.

(c) Documentation of corrective action, including that required by section 70-3.2, of this Subpart, shall be retained for three (3) years.

(d) Documentation of any modification to an approved operation plan, regardless of whether the modification is subject to Department approval pursuant to this section, shall be retained three (3) years

from discontinuance of the modified plan.

(e) Documentation of the residence time, pressure and temperature of each load treated shall be retained for three (3) years.

(f) All records required pursuant to this section shall be made available for inspection and

copying by the Department.


VOLUME A-1a (Title 10)