ASTM E3263-22e1

$41

Click Here Concat Us

ASTM E3263-22e1

2022

Most Recent

Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

PDF FORMAT
Printable
Download
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM E3263-22e1
STANDARD INFO:
Standard NameASTM E3263-22e1
ScopeStandard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
PublisherASTM - ASTM International
LanguagesEnglish
State
Publication Year2022
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
File Size1 file , 1 MB
NoteThis product is unavailable in Russia, Ukraine, Belarus
Number of Pages21
Published05/01/2022
This document does not provide a preview.
ASTM E3263-22e1
HistoryPublisher Year
ASTM E3263-22e12022Current
ASTM E3263-222022
ASTM E3263-202020

Related products

ASTM E2975-24
Standard Test Method for Calibration or Calibration Verification of Constant Speed Concentric Cylinder Rotational Viscometers
Most Recent

$31

ASTM E1384-07(2013)
Standard Practice for Content and Structure of the Electronic Health Record (EHR) (Withdrawn 2017)
Most Recent

$60

ASTM E2473-05(2011)
Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record (Withdrawn 2020)
Most Recent

$43

ASTM E1988-98
Standard Guide for Training of Persons who have Access to Health Information (Withdrawn 2007)
Most Recent

$25

individual-home

Over 3,000,000 global standards

Our standards library is extensive, with over 2 million documents, ensuring we meet the needs of various industries. Whether it’s ASME, DIN, ASTM or ISO and other internationally recognized standards, we offer complete documents and the latest versions to help customers adhere to industry regulations in their projects. Whether your needs are technical standards, regulatory requirements, or design guidelines, our standards library provides comprehensive support.

24 online customer service

Our team includes up to 50 engineers from fields such as healthcare, electronics, and construction, who can answer your technical questions and ensure you find the correct and accurate standard documents. We are dedicated to helping you find the best solution that meets your needs.

The reviews
What People Are Saying

Thanks to the StandardsClub customer service team for helping me find the ASME BPVC-2023 SET I was looking for in a high-quality PDF version. Their assistance was excellent, and the document quality exceeded my expectations!

This standard document is very detailed, covering all relevant technical points, and provides comprehensive guidance for my project. The ANSI/NEMA Z535 SET was exactly what I needed, and I am very satisfied with the quality!

The purchasing process was straightforward, the price was very competitive, and the download was quick. The Tissue Engineering Standards Addressing Product Quality and Characterization Package was of excellent quality and provided all the information I needed. Definitely a great value for the price!

HAVE A QUESTIONS ABOUT?
Everything is here to help you.

“Got questions? Our professional customer service is ready to assist you anytime. Whether it’s finding documents, getting discounts, or navigating the purchase process, let us help you get the standards you need!”

Sign Up Our Newsletter

Don’t miss out! Subscribe now to get exclusive offers and industry insights!

We care about your data in ou privacy policy.

Shopping Cart
Scroll to Top