Mail: info@sterilize.it  – Linkedin: sterilize.it


  • Member Area
  • Registration
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us

Cycle development: A Practitioner’s Guide

Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.11)

Cycle development is the process of determining the physical properties to be met in a sterilization cycle that will be used to reproducibly and consistently sterilize the product, component, and/or equipment in a defined loading pattern. The goal of cycle development is to provide a proven acceptable range of sterilizing conditions that result in a product/material that is both sterile and functional after the completion of the sterilization cycle. The cycle development goals are often established in a formalized development plan. This frequently is written as a protocol or a standard operating procedure (SOP). There are many functional group interactions and sterilization-related
activities associated with conducting cycle development studies necessary for a regulatory filing. The activities associated with developing sterilization technology data for a new or modified drug product require the interaction of several disciplines.

– How Does One Determine Whether the Product Withstands a Thermal Process That Is Encountered in Moist Heat Sterilization?

Generally, pilot plant or bench top laboratory studies are conducted, whereby the formulated product in the intended container/closure system is exposed to maximum anticipated thermal and time conditions. At this point, one would have to speculate on what the maximum conditions of the sterilization process would be. Following thermal exposure per the maximum sterilization cycle conditions, the drug product is tested to ensure that the product remains within the specification limits.

More than one set of cycle parameters may be evaluated, such as variable times and temperature conditions, to determine whether a heat sensitive product is compatible with a terminal sterilization process. These evaluations could be classified as initial R&D stability studies. Further, thermally exposed products should be placed on accelerated 40°C stability studies for at least three months. If the product stability data demonstrate that the initial product specification release limits cannot be maintained, a case exists for aseptically processing the product. These data would have to be included in the NDA or European regulatory submission.

During the review process, questions may arise regarding whether extractables from the container/closure system influenced the drug or product data. Therefore, the developmental data must show whether the system will meet
the USP biological safety testing if the container/closure system is an elastomeric, plastic, or other polymeric material.

 

 

Tasks presented in the chapter :

– Expectations of Regulatory Agencies Concerning Sterilization of the Solution and Cycle Selection on the Basis of     Solution Selection—Development Studies That Need to Be Conducted

– Defining requirements

– Selection of a moist heat sterilization process

– Container thermal mapping: determining the slowest-to-heat zone

– How much lethality is enough?

– What Is the Purpose of the D- and z-values?

– Determining the Minimum Microbial Lethality

– Determination of the Probability of Survival for Bioburden

– Determination of the required sterilization process time (in minutes of F0) or cycle definition (load probe controlled cycles)

-Required Sterilization Process Time

– Cycle Definition (Product Penetration Controlled Cycles, i.e., controlled by Fo values in solution filled containers)

– The container/closure system

– True Fo cannot be calculated at closure sites

– Regulatory expectations for container/Closure challenge data

– Syringes

– The master solution – biological  challenge

– How does one select the Master Solution?

– Special considerations related to the design of the subprocess solution challenge

– Calculation of the required heat history for processes at temperatures other than 121°C

– Fractional or half-cycle developement approaches

– Container closure integrity testing

– The master solution – heat penetration

– The Master Equipment Challeng

– What thermal distribution and penetration data are expected?                                                                                          –

– Heat Penetration (Thermoprobed Product)

– Temperature Distribution Studies

– Time windows

– Cycle Come-Up Time or Heat-Up Time*

– Exposure Time

– Calculation of Cooling Times

– Loading patterns and configurations drying cycles

– Sterilization and integrity of filters

– Cooling water evaluations

Conclusion

Development of an appropriate sterilization cycle is difficult.  The development of an efficacious and yet economic sterilization process is one of the most critical phases of a product development process. This chapter is intended to provide some guidance on the topic. However, each site needs to have an established cycle development program that takes into account the facilities and equipment actually used.

[…]

                                                                                                                                  Courtesy of DHI Publications.

  • author: Korczynski Michael and Moldenhauer Jeanne

The content you requested is only available for registered users. Please, register to download the file.
It's fast and free. Register here.
If you are a registered user enter your e-mail address and password to log in.

• Download
PDF File

0
0
0
0

related articles

  • Decontamination with hydrogen peroxide: use and technical developments
  • A history of isolator and containment technology, Part 6: Development of the validation of isolators
  • Highlights on F0
  • ISO 14644 – Revision to Parts 1 and 2
  • History of isolator and containment technology Part 1: Early containment leading to flexible film isolator

0 Commenti

Leave Reply Annulla risposta

Il tuo indirizzo email non sarà pubblicato. I campi obbligatori sono contrassegnati *

Search
  • Enter your keyword

  • Processes

  • Applications

  • Author

Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding

What is a sterilization autoclave?

Product Stability Issues

Scroll
Contact

Mail: info@sterilize.it
Linkedin: sterilize.it

Member Area
Accesso
Password persa
Process
  • Aseptic processing
  • Cleaning
  • Chemical bio-decontamination
  • Moist-heat sterilization
  • Sterilization
Application
  • Blood bags
  • Environmental Monitoring
  • Food
  • General
  • Hyaluronic Acid
  • Other applications
  • Package Integrity
  • Pharma – Liquids
  • Pharmaceutical compounding
  • Pre-filled syringes (PFSs)
  • Robotics
  • Sealed containers
  • Validation
Subscribe to newsletter

Subscribe to our newsletter to stay informed about our news and info.

Join here

© Copyright 2020 Sterilize.it. All rights reserved. Privacy Policy e Cookie

Fedegari Autoclavi SpA | Albuzzano - SS 235 Km 8, CAP. 27010 (PV) | REA: PV- 130961 | P.IVA IT00303010185 | PEC: amministrazione@pec.fedegari.com | Capitale Sociale Versato 5.000.000,00 € i.v.