Clean validation

Berg, T., Humphreys, P., Phillips, B. and Scherz, B., Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation , PIC Publication PH 1/96. [Pg.520]

Approaches to Process Validation Process Validation Program Periodic Review of Validated Systems Cleaning Validation Validation of Analytical methods Change Control, Rejection, and Reuse of Materials Rejection Reprocessing Reworking... [Pg.286]

Source Parenteral Drug Association. Technical report No. 29, Points to consider for cleaning validation, PDA Journal of Pharmaceutical Science and Technology 52 Nov-Dec Supplement (1998). [Pg.301]

Brunkow R, DeLucia D, Green G, et al. Cleaning and Cleaning Validation A Biotechnology Perspective, PDA, Bethesda, MD, 1996. [Pg.317]

Disadvantages Cells only grow when attached to solid substrates cells require additional attachment factor not easy to scale up more cleaning validation issues and high disposal cost more difficult to operate than suspension process... [Pg.346]

Finally, we will discuss the determination of the limit of quantitation or LOQ. Establishing an LOQ is required for many pharmaceutical applications such as impurity testing and cleaning validation. Limit of quantitation is the lowest concentration (%, ppm) that can be determined with acceptable precision (RSD of —5%). It is generally accepted that a signal/noise ratio at the LOQ should be at least There are... [Pg.43]

Cleaning validation 6 replicates at 10 x LOQ Relative standard deviation NMT 20%... [Pg.206]

HPLC is the leading Analytical procedure used for the verification of pharmaceutical cleaning validation programs. HPLC provides a linear, sensitive method for quantitating low levels of residues making the chromatographic finish the most reliable part of the cleaning verification. [Pg.401]

Analytical Methodology The Heart of Cleaning Validation, Presented at the 42nd Annual Conference on Pharmaceutical Analysis, July 30, 2002, Merrimac, Wisconsin and 26th Puerto Rico Pharmaceutical Quality Association, January 28,2003, San Juan, Puerto Rico. [Pg.412]

HPLC applications assays, impurity evaluation, dissolution testing, cleaning validation, high-throughput screening, and chiral separations (Chapters 13-18). [Pg.674]

N.K. Mehta, J. Goenaga-Polo, S.P Hemandez-Rivera, D. Hernandez, M.A. Thomson and P.J. MeUing, Development of an in situ spectroscopic method for cleaning validation using mid-IR fiber optics. Spectroscopy, 18(4), 14 (2003). [Pg.461]

M.L. Hamilton, B.B. Perston, PW. Harland, B.E. Williamson, M.A. Thomson and P.J. Melling, Grazing-angle fiber-optic IRRAS for in situ cleaning validation, Org. Process Res. Dev., 9, 337-343 (2005). [Pg.461]

Potentially useful in cleaning validation, which is part of the manufacture of pharmaceuticals. [Pg.277]

The cleaning validation is required to demonstrate that, after cleaning, the equipment and surfaces are essentially free from product residues and traces of cleaning agents to prevent cross-contamination. [Pg.13]

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