Clean-in-Place for the Biopharmaceutical Processes - download pdf or read online

By Dale A. Seiberling

ISBN-10: 0849340691

ISBN-13: 9780849340697

ISBN-10: 1420014056

ISBN-13: 9781420014051

This advisor illustrates most sensible practices and profitable purposes of CIP in either pharmaceutical and biotechnology amenities. providing reader-friendly descriptions of a number of the different types of apparatus and fabrics present in average CIP approaches, Clean-In-Place For Biopharmaceutical techniques will take the guess-work out of CIP improvement, and illustrate all one must recognize for the institution and optimum functioning of a CIP procedure.

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Additional info for Clean-in-Place for the Biopharmaceutical Processes

Example text

The flush, wash, and rinse solutions would follow the flow path designated by the (T) arrow heads in Figure 7 for the full duration of the CIP CIPS1 CIP return L AWFI Vent T,L CIP skid T CA T1 L T2V3 Vent filter T1V1 (Pulse) T,L T2V4 T2V1 T,L T,L T2 T L CS CS T Drain T1V2 L AWFI Vent T1V3 CIPS2 (Intermittent) Transfer line T CA Vent filter AWFI (Pulse) CIPS3 L Next tank T,L TP1 T2V2 TP2 CIP flush line CIP supply L CIP return T,L CIP return pump FIGURE 7 This schematic has been heavy lined to define the tank circuit flow path by arrow heads (T) and the line circuit flow path by arrow heads (L).

Postwash Rinse Following the solution wash, a minimum of softened water will be used to flush the soil and alkaline solution from the equipment surfaces. Neither sodium hydroxide nor potassium hydroxide is free rinsing, however, and whereas the simple check of conductivity at the discharge to drain may suggest that the alkaline material has been removed early in the rinse, sampling of the equipment surface may reveal a considerable alkali residual. 0 (just slightly on the acid side of neutral). This solution, recirculated at the water supply temperature (no additional heating), will neutralize all traces of alkali residual on the equipment surfaces.

Pharm Eng 1986; 6(6):30–5. 7. Seiberling DA. Clean-in-place/sterilize-in-place (CIP/SIP). In: Olson WP, Groves MJ, eds. Aseptic Pharmaceutical Manufacturing. 1st ed. , 1987:247–314. 8. Adams DG, Agaarwal D. CIP system design and installation. Pharm Eng 1992; 10(6):9–15. 9. Seiberling DA. Alternatives to conventional process/CIP design—for improved cleanability. Pharm Eng 1992; 12(2):16–26. 10. Seiberling DA, Ratz AJ. Engineering considerations for CIP/SIP. In: Avis KE, ed. Sterile Pharmaceutical Products—Process Engineering Applications.

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Clean-in-Place for the Biopharmaceutical Processes by Dale A. Seiberling

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