Validation Practices for Biotechnology Products

STP Published: 1996

STP1260-EB

Validation Practices for Biotechnology Products

Editor(s): James K. Shillenn

The first reference source of its kind dedicated to current innovative approaches to high standard validation practices for biotechnological uses in the pharmaceutical industry.

12 comprehensive peer-reviewed papers cover the following critical areas: Facilities and Equipment Validation; Process Validation and Planning; and Calibration and Change Control.

STP Individual Article Download Free

Commissioning Major Pharmaceutical Manufacturing Facilities

ST Fay, TP Howard, WT Stevens

Validation of Filters Used for Sterilizing Liquids

JM Martin, S Cole, G Geerligs, G Howard, R Jaenchen

Points to Consider Before Validating a Liquid Nitrogen Freezer

FP Simione, JZ Karpinsky

Standards and Practices for Computer Validation and System Definition

RW Stotz, AR Bluhm

Validation Studies in the Regeneration of Ion-Exchange Celluloses

PR Levison, M Streater, RMH Jones, ND Pathirana

Sensitivity Considerations in Hydrophobic Filter Integrity Testing

WC Steere, LA Scheer, M Hubbert

Designing Validation into Chromatography Processes

GK Sofer

Developing Procedures to Meet GMP Requirements

MJ Malooley

Process Development, Scale-Up and Validation of a Recombinant -Based Fermentation Process

KS Sniff, LA Garcia, RA Hassler, RJ Seely, MD Young

A New Methodology for Quality Control Testing of Biological and Recombinant Products

BY Zaslavsky, DJ Chaiko

Validation of Disinfectants Used in Biotechnology Facilities

SG Richter

Staying in Control — Ongoing Calibration and Change Control Practices

JT Busfield

Shipping & Handling

Domestic Shipping

Domestic orders are delivered via United Parcel Service (UPS) or United States Postal Service (USPS). Transit times average 3 to 5 business days. Please be aware that UPS will not deliver packages to Post Office Boxes.

Domestic Rush Orders

Please Contact Us.

International Standard Shipping

International orders are delivered via courier post services which can be either a postal service, courier service, or a combination of both. Standard Service is untraceable. Please allow 4-7 weeks for delivery.

International Expedited Shipping

Please Contact Us.

Please be aware that carriers will not deliver packages to Post Office Boxes. Because of the variability of customs processes and procedures in different countries, ASTM International cannot guarantee transit times to international destinations. Customs duty and taxes are the responsibility of the consignee.

Shipping & Handling charges follow the rate schedule, below:

Order Total	Shipping & Handling Fee (US Domestic)
Up to $50.00	$18.72
$50.01 to $100.00	$20.80
$100.01 to $150.00	$29.52
$150.01 to $250.00	$39.09
$250.01 to $500.00	$56.25
$500.01 to $750.00	$76.42
$750.01 to $1000.00	$93.15
$1000.01 to $1500.00	$121.27
$1500.01 to $2500.00	$158.38
$2500.01 to $4999.00	$209.04
$5000.00 to higher	FREE

Order Total	Shipping & Handling Fee (International)
Up to $50.00	$68.72
$50.01 to $100.00	$70.80
$100.01 to $150.00	$79.52
$150.01 to $250.00	$89.09
$250.01 to $500.00	$106.25
$500.01 to $750.00	$126.42
$750.01 to $1000.00	$143.15
$1000.01 to $1500.00	$171.27
$1500.01 to $2500.00	$208.38
$2500.01 to $4999.00	$259.04
$5000.00 to higher	FREE

Shipping and Handling charges are approximate. Additional charges may be incurred if your order requires multiple shipments. This does not apply to complete sets and sections.

ASTM License Agreement

Reprints and Permissions

Reprints and copyright permissions can be requested through the
Copyright Clearance Center

Details

Developed by Committee: E48

Pages: 160

DOI: 10.1520/STP1260-EB

ISBN-EB: 978-0-8031-5322-6

ISBN-13: 978-0-8031-2405-9