The Myth Called "Sterility" - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Myth Called "Sterility"
The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 34

Equipment and utensils:

  • Product-contact surfaces of equipment must be sterilized using a validated method (vibratory feed systems may be exempted from this requirement provided they are high level decontaminated with a sporicidal agent in-situ)
  • Sterilization-in-place and clean-in-place should be used wherever possible
  • Equipment should be assembled to the fullest extent possible prior to sterilization
  • Equipment and utensils should be sterilized in sealed containers (the use of paper and tape is not recommended)
  • Equipment and utensils should be introduced in a manner that retains at least one layer of sterilized-protective covering or wrap until entry into the critical zone
  • Equipment and utensils should be sterilized/depyrogenated using a just-in-time approach
  • Inventories of materials in the aseptic environment should be minimized
  • Equipment should be selected for high reliability, ease of changeover, and adjustment
  • Remote adjustment of equipment should be utilized where possible
  • Tool free change over from one format to another should be possible
  • Equipment should be tolerant of container-closure miss-feeds, jams, and other problems to minimize the need for interventions
  • Equipment (and to some extent facility) should use process analytical technology and other feedback systems for ease of control, operation, and documentation
  • Non-product contact portions of the equipment should be easily decontaminated and non-invasive of the critical zone
  • All equipment surfaces should be resistant to the potential corrosive action of sanitizing and decontamination agents.

Containersand closures:

  • Containers and closures must be prepared and sterilized/de-pyrogenated using a validated process
  • Containers and closures should be introduced in a manner that retains at least one layer of sterilized-protective covering or wrap until entry into the critical zone
  • Containers and closures should be selected for reliability of handling in the processing equipment
  • Containers and closures should be suitable quality for their intended use because higher acceptable quality levels for defects can result in a reduction in the need for interventions
  • Containers and closures should be sterilized/depyrogenated using a just-in-time approach.

Product:

  • Product materials must be prepared and sterilized using validated methods
  • Product delivery should be made directly into the critical zone
  • Where product is supplied to the critical zone in sterile container (e.g., sterile powders), it should be introduced in a manner that retains at least one layer of sterilized-protective covering or wrap until entry into the critical zone.

Personnel:

  • Personnel must receive initial and periodic training in current good manufacturing practice, aseptic processing, microbiology, aseptic gowning, and job specific tasks
  • Where appropriate, personnel should be initially and, periodically thereafter, assessed for their proficiency in aseptic gowning
  • Personnel should be initially and, periodically thereafter, assessed for their proficiency in aseptic technique
  • Personnel should be monitored upon each exit from the aseptic core (gloves on enclosures should be monitored at the end of the batch or campaign)
  • Gown materials should be cleaned and sterilized using validated methods
  • Gloves on enclosures should be replaced periodically, sterilized, and integrity tested
  • Personnel should be trained and diligent in their adherence to aseptic techniques
  • Manual filling by aseptically-gowned personnel should be recognized as an anachronistic throwback to an earlier time and no longer used for aseptic processing.

Procedures:

  • Procedures should be reviewed to eliminate unnecessary work steps and simplify aseptic processes
  • Interventions should be designed for minimal risk of contaminating sterile materials
  • Interventions performed during aseptic processing must be recognized as increasing the risk of contamination dissemination
  • All interventions should be performed using sterilized tools whenever possible
  • Intervention procedures should be established in detail for all inherent interventions and, more broadly, for corrective interventions (where some flexibility is necessary due to their greater diversity).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here