Description

This Lyophilization Validation Protocol Template is an NFT (Non-Fungible Token) downloadable MSWord document ready to use in a planned and systematic manner to handle your needs of Freeze Drying process validation & equipment’s performance qualification (PQ) as per 21 CFR Part 211 and Part 820.

In addition, this PQ Protocol template is intended to facilitate the collection of the documented evidence necessary to establish that your lyophilizer is suitable to work for your product(s) and application(s) properly according to the manufacturer’s recommendations and design specifications.

This 28-page document is the first collectible digital asset of a Performance Qualification Protocol Template (Limited Edition) available in MS Word and Adobe .pdf format from the NFT marketplace.   It contains copyright information only authorized to be used within your company.

To download a free sample of the Lyophilization Validation Protocol Template, click here.  

This protocol template is an NFT digital asset intended to set forth the instructions to create and implement a performance qualification protocol for any kind of lyophilization process and equipment.  It describes the methodology (steps-by-steps) for the execution of performance qualification activities according to the FDA process validation guidelines.

Purpose of the Lyophilization Validation Protocol Template

The purpose of this protocol is to qualify the performance of the Freeze Dryer equipment to remove free-water molecules in pharmaceutical products considering your own uploading configuration(s) and cycle parameters.

This protocol aims to demonstrate that the freeze-drying process is reliable for rendering a lyophilized product according to a predetermined cycle design, parameters, and specifications in compliance with the quality system regulations 21 CFR Part 210 and 211.

Three (3) lyophilization phases will be considered in this qualification.

• Freezing Stage – Phase 1
• Primary Drying (Sublimation) Stage – Phase 2
• Secondary Drying (Adsorption) Stage – Phase 3

Lyophilization Validation Scope

The scope of this lyophilization validation considers the following seven (7) areas:

• Dissolving the drug and excipients in a suitable solvent, generally water for injection (WFI).
• Sterilizing the bulk solution by passing it through a 0.22µ micron bacteria-retentive filter.
• Filling into individual sterile containers and partially stoppering the containers under aseptic conditions.
• Transporting the partially stoppered containers to the freeze dryer and loading them into the chamber under aseptic conditions.
• Freeze the solution by placing the partially stoppered containers on cooled shelves in a freeze-drying chamber or pre-freezing in another chamber.
• Applying a vacuum to the chamber and heating the shelves in order to evaporate the water from the frozen state.
• Complete stoppering of the vials usually by hydraulic or screw rod stoppering mechanisms installed in the freeze dryers.

Lyophilization Definition

Lyophilization or freeze drying is a process to remove free water from a product after it is frozen and placed under a vacuum, allowing the ice to get separated from the product into small microscopic crystals ready to change directly from solid to vapor without passing through a liquid phase.

Lyophilization is a drying process that works by first (1) freezing the material, (2) second reducing the pressure, and third (3) adding heat slowly again until ambient temperature to allow the frozen water to sublimate in vapor.

Sublimation occurs at low temperature and pressures when freezing the product, then removing the ice (dehydration) to vapor meanwhile the temperature increases slowly until reach ambient temperature.

Sublimation is a particular way to remove water from a heat-sensitive product, different from the conventional method that evaporates water using high temperatures.

Lyophilization, also known as freeze drying or cryodesiccation, is the most expensive way to remove water from a product at very low temperatures and pressures.

At some point (Eutectic Point or Eutectic Temperature), the water pass from solid to gas in a process called Sublimation. The product must be frozen at a temperature below the eutectic point.

Lyophilization Validation Protocol Description

For this protocol execution, three (dummy loads or real product loads) validation runs will be evaluated. These product loads will be composed of a predetermined number of trays filled with an equivalent amount of water and trays.

For cycle development and validation purposes, a dummy configuration will simulate the load used for normal lyophilization cycles.

The main sections of this Lyophilization Validation protocol template are:

• • Purpose
  • Scope
  • Responsibilities
  • Freeze Dryer Description
  • Measuring And Test Equipment
  • Procedure
  • Lyophilization Process
  • Acceptance Criteria
  • Abbreviations
  • Associated Reference Documents
  • History Of Change
  • Document Approval

Important Note:

Once you build your own lyophilization validation protocol using this template, you can resell the same NFT if you want in the NFT marketplace to make profits from your investment.

In addition, it allows you the mechanism to handle the lyophilization validation documentation related to your validation work that needs to be addressed and mitigated in the most simple way.

 

SPECIAL BONUS

This protocol template describes how to perform the most relevant lyophilization validation activities applicable to your freeze dryer and other supporting equipment in a practical way using ( 12 ) template forms, as applicable to each case in your pharmaceutical and medical devices company:

• • Template Form #1 – Instruments Calibration Id and Due Date
  • Template Form #2 – List of Standard Operating Procedures
  • Template Form #3 – Thermocouple and Tray Placement
  • Template Form #4 – Process Data Collection Form
  • Template Form #5 – Lyophilization Cycle Parameters
  • Template Form #6 – Acceptance Criteria for Process Parameters
  • Template Form #7 – Process Times
  • Template Form #8 – Protocol Deviation Log
  • Template Form #9 – Protocol Deviation Report
  • Template Form #10 – Supporting Documentation Log
  • Template Form #11 – Supporting Documentation
  • Template Form #12 – Under Qualification Identification Form

 

Don’t lose this extraordinary investment opportunity to get a utility NFT protocol template written by the experienced author: Ramon Cayuela, CIQA Director.

Buy now.

Avoid Mistakes Implementing a Lyophilization Validation Protocol.

Step 1. Review the applicable validation plan(s), equipment manual(s), design specification(s), and current SOP standard operating procedure(s) concerned with your freeze-drying operation.

Step 2. Compare your lyophilization validation protocol against the current practice and actual use of your freeze dryer considering any update(s) or change control(s) made, actual load configuration(s), temperature specifications, or pressure parameters included in your standard operating procedures.

Step 3. Also consider the applicable FDA validation requirements versus your current lyophilization validation protocol’s activities performed previously in your company, but also the applicable software validation guidelines that need to be challenged and documented, if necessary.

Step 4. Evaluate the lyophilization validation protocol’s specifications and results obtained in your previous PQ studies, but also how you established your protocol’s acceptance criteria, risks, and how fast you need to perform and close each new lyophilization validation protocol update including any pending item or future improvement.

Step 5. Implement a robust and efficient lyophilization validation program to handle the overall freeze-drying process validation, gaps, or any discrepancy that could be found.

For more information, visit www.ciqa.net/shop to download other Validation Protocol Templates in .pdf format or fully editable in MS Word format, ready to fill, and use according to your cGMP needs at affordable prices.

ADDITIONAL VALIDATION PROTOCOL TEMPLATES ARE AVAILABLE IN MSWORD, SOLD SEPARATELY.
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QMS Software Applications

In addition, the lyophilization validation records and documentation can be handled electronically using QMS software applications.  For more information about  Quality Management System (QMS) Software Applications, click here.

About The Author:

Ramon Cayuela Melendez, CIQA Director

Bachelor’s and Master’s Degrees in Chemical Engineering from the University of Mayaguez, Puerto Rico.

30+ years of experience in Quality System Regulations serving more than 1,000 clients in over 100 multinational companies related to pharmaceutical, biotechnology, food & medical devices.

Manager & Senior Scientist with proficient skills and experience in Pharmaceutical Validations, Quality Assurance, Regulatory Compliance, Research & Development (R&D), GMP/ISO Audits, CAPA, Automation & Software Development.

Author of over 250 Quality Management Procedures and Validation Protocols Templates NFTs.

United States & European Citizens.  Speak English & Spanish.

 

 

CIQA is a validation, quality, and regulatory compliance company with over 30 years of experience bringing consulting services to the pharmaceutical, medical device, and biotechnology industries.