2250081 Preview

PDA TR 13-2

Technical Report No. 13-2 Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products

Report / Survey by Parenteral Drug Association , 11/01/2020

View all product details

Most Recent

Track It

Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Secure PDF 🔒
    • Immediate download
    • $325.00
    • Add to Cart
    • Printed Edition
    • Ships in 1-2 business days
    • $375.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $439.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

TR-13-2 focuses on environmental controls and monitoring programs for classified areas where manufacturing processes are required to ensure a low bioburden level of the material being produced. Although a comprehensive EM program addresses both viable and nonviable aspects of the facility, this addendum concentrates primarily on the viable aspects as these parameters have a greater potential to impact product and process quality related to bioburden. This document is not intended to address EM programs for traditional aseptic or sterile manufacturing, which are covered in TR-13, nor does it address traditional nonsterile dosage forms.

 

Product Details

Published:
11/01/2020
ISBN(s):
9781945584213
Number of Pages:
29
File Size:
1 file , 390 KB