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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi
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Sterilization with Hydrogen peroxide

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Sterilization with Hydrogen peroxide

Author: Mr. Prashant  Suresh  Devmore,                   Mail Id: prashantdevmore@hotmail.com
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Pharmaceutical companies are manufacturing the products which deal with our lives. So, it is our prime responsibility that these manufacturing activities shall be executed in a clean environment that is free from microorganisms.

Previously many pharmaceutical companies are doing periodic fumigation with formaldehyde. But, formaldehyde being carcinogenic in nature is highly dangerous to people working in pharmaceutical companies and for the environment. As a replacement to formaldehyde only one methodology is available in the current scenario. That is Sterilization with Hydrogen peroxide  (H2O2). So, airborne disinfection in pharmaceutical companies has developed. So, in this post, we will understand the following,

How Sterilization with Hydrogen peroxide is done?

Sterilization with Hydrogen peroxide is done by means of a dry mist generator, that generates mist and spreads at every corner of the area. The speed of generated mist is depended upon machine capacity. More speed more chances to reach every corner of the area.

Sterilization with Hydrogen peroxide

How Sterilization with Hydrogen peroxide is performed in the pharmaceutical?

The first process is to qualify the disinfection machine that is selected and procured for airborne disinfection activity. The room-specific cycle shall be developed mentioning the conc. of H2O2. If these developed cycles are satisfactorily validated, then cycles can be used for periodic airborne disinfection activity. The frequency of the airborne disinfection activity shall be predefined.

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Airborne disinfection:

There are multiple ways of disinfection of the areas/ objects. For e.g. surface sanitization, cleaning and fogging. However, all the methods do not remove vegetative forms of the bacteria. Hence to have a robust disinfection procedure, nowadays airborne disinfection methodology is in trend. In this method, the disinfectant is spread across the area by means of a fine mist generating machine.

Why Sterilization with Hydrogen peroxide is required?

As I said, all the disinfectants are not killing the vegetative spores of microbes, hence to have the combined effect of protein denaturation and killing of spores, airborne disinfection is required.

Which chemical is used for airborne disinfection in the pharmaceutical?

Hydrogen peroxide is used for airborne disinfection activity in pharmaceuticals. There are N no. of equipment that can create a fine mist of hydrogen peroxide with spreading capacity. By means of this equipment, the hydrogen peroxide can be spread in the targeted areas for airborne disinfection.

Sterilization with Hydrogen peroxide

How Sterilization with Hydrogen peroxide procedure is validated? What is a sequence of airborne disinfection in pharmaceuticals?

Validation /Qualification of Sterilization with Hydrogen peroxide:

1. User Requirement Specification

In this phase, the user requirements pertaining to room dimension, disinfection machine capacity, required speed shall be evaluated. Ensure that, the machine should have a delayed start time.

2. Design Qualification

The user requirements and supplier specifications shall be compared for ensuring all user requirements are fulfilled with selected equipment.

3. Installation Qualification

Equipment is installed in this phase. During installation, the machine speed, machine compatibility, machine capacity is ensured.

4. Operational Qualification

In this stage, the machine shall be operated at its designed specification. During this phase, it is ensured that the machine operated as per proposed user requirements and fulfills the design requirements. For execution, the room in which decontamination is planned shall be evaluated for its dimensions, feasibility of H2O2, and machine location determination.

Hydrogen peroxide (H2O2) comes in different concentrations. More is the concentration, no doubt, it will clear the contamination level, but it will affect more to the existing equipment, facility in the area. So, the determination of the lowest concentration that can be effective to kill microorganisms shall be determined in the operational qualification phase.

Before execution determine the HVAC of the area is in closed condition for a defined period. After exposure, the H2O2 required contact time, to kill the microorganism. In this phase, the H2O2 mist will spread on microorganism surfaces. After a few minutes of contact time, the air circulation should start.

Precaution:

Hydrogen peroxide is highly dangerous. Hence during the execution of the cycle, avoid physical contact with H2O2. Use the delay time feature of the machine for activation of the cycle.

The operation includes a few stages, like

  • Generation of mist,
  • Spreading of mist
  • Contact time
  • Removal or deactivation of H2O2

The process is tabulated below,

  • Identification of area
  • Cycle development
  • Determination of qty. required for decontamination (H2O2 qty.)
  • Determination of H2O2 concentration required for decontamination
  • Determination of equipment positioning
  • Identification of the worst-case location
  • Positioning of the chemical and biological indicators at the proposed area.
  • Execution of cycle
  • If the cycles are passing, use the conc. of H2O2 for further processing.

5. Performance qualification

Execution of developed cycle for 3 consecutive times for the same area with biological and chemical indicators.

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