Guardians of Purity: Particulate Matter Counters in Pharma

Table Of Contents

1. Introduction
2. What is Microscopic Particulate Matter?
3. Why is it important to measure microscopic particulate matter?
4. Microscopic Particulate Matter Counters
5. Microscopic Particulate Matter Counters in Pharma
6. ImageProVision Solution
7. Summary

Introduction

A microscopic particulate matter counter proves to be a crucial tool across various industries. This sophisticated instrument is specifically designed to detect and quantify particulate matter in the different forms of samples. 

This article discusses microscopic particulate matter, the types of counters, and more. Keep reading to learn more…

What is Microscopic Particulate matter? 

Microscopic particulate matter is tiny particles suspended in the air and not individually visible to the naked eye because of their size. The size of these particles can be less than 2.5 micrometers or range from 2.5 (PM2.5) to 10 micrometers (PM10). They may comprise dust, pollen, soot, smoke, liquid droplets, and other pollutants from multiple sources.

PM2.5 particles get in pharma products like injections, ophthalmics, and MDIs (Metered Dose Inhalers) from sources like the environment, packaging materials, and undissolved formulation ingredients raise a serious concern. The presence of these particles is highly concerning due to their size, as they can easily make their way into the respiratory system when inhaled, reach the smallest airways of the lungs, and finally enter the bloodstream. 

Check this video on particulate matter: https://www.youtube.com/watch?v=zRS69Kf--fU

Why is it important to measure microscopic particulate matter

Detection of particulate matter in the pharma industry is mandatory for several reasons:

A) Product Quality and Safety: Since the Particulate matter in pharma products may originate from sources like raw materials, manufacturing processes, and packaging, keeping an eye on them ensures product quality and safety. Excessive amounts of particulate matter in drugs can pose severe threats like injection to site reactions, embolism, and any other adverse effects to the consumers. 

B) Compliance with Regulations: Regulatory bodies like the Food and Drug Administration have laid stringent guidelines for particulate matter in pharma products. It is, therefore, mandatory for Pharmaceutical companies to comply with these regulations to make sure their products meet quality standards and are safe for consumption.

C) Quality Control in Manufacturing: During the process of drug formulation, manufacturing, and packaging, monitoring the particulate matter is crucial as it helps to identify and control the sources of contamination. 

D) Stability and Shelf Life: Since Particulate matter can affect pharmaceutical products' stability and shelf life, supervision over particulate contamination helps maintain the efficacy and integrity of the drug during its intended shelf life.

Microscopic Particulate Matter Counter

A microscopic particulate matter counter is an instrument specifically designed to detect, quantify, and categorize the concentration of particulate matter. 

Different types of microscopic particulate matter counters that employ distinct principles for particle detection are available; some are discussed in this section: 

E) Optical Particle Counters (OPC): These devices use light scattering or light-blocking techniques for detecting particles when they pass through a detection zone. An Optical Particle Counter can provide real-time measurements of the number and size distribution of particles in the sample.

Check the video to learn how Optical Particle Counters work: https://www.youtube.com/watch?v=F7PkGzt6xr0.

F) Condensation Particle Counters (CPC): A CPC condenses vapor, enlarging its size and enabling its detection and quantification. CPCs are highly sensitive to ultrafine particles.

Check this video to learn about the functioning of Condensation Particle Counters: https://www.youtube.com/watch?v=Msu-9YgvjCs

G) Beta Attenuation: A Beta Attenuation Mass Monitor (BAM) or Beta Attenuation Particle Mass Monitor (BAPMM) is used to determine the mass concentration of particulate matter and works on beta radiation attenuation through the filter. The instrument contains a beta radiation source, Strontium-90 (a radioactive isotope), which emits beta particles. The sample is drawn into the device through a filter, and the particulate matter gets deposited on the filter. When the emitted beta particles pass through the filter, the radiation is absorbed by the particles, reducing the intensity of the radiation. 

H) Gravimetric Method: The particulate matter is collected on filter paper and weighed to determine its mass. This method is considered a reference standard for PM measurement and is mainly used for regulatory compliance.

Check this video to learn about the Gravimetric method: https://www.youtube.com/watch?v=KlFfuaSbybQ.

I) Scanning Mobility Particle Sizers (SMPS): SMPS is an advanced instrument used to measure the size distribution of particulate matter. It is highly effective in providing insights about the different sizes of particles and their concentration. The SMPS distinguishes particulate matter based on its electrical mobility, which is influenced by size and charge. 

Check this video to learn more about SMPS: https://www.youtube.com/watch?v=esfmVsFrzVE.

These particulate matter counters are often used to check air and water quality, along with R&D purposes. Monitoring particulate matter is important because exposure to high levels of specific particle sizes might have adverse effects on the health of human beings, primarily respiratory and cardiovascular systems. 

Particulate Matter Counters In Pharma

When particles enter the bloodstream, they can be dangerous. Considering these hazards, the US pharmacopeia restricts the quantity of particulate matter permitted in injections and ophthalmic solutions, described in USP<788>, USP <789>, USP <1788.2>, and 〈790〉.

Two methods, namely the Light Obscuration Particle Count Test and Microscopic Particle filter paper analysis, are recommended by regulatory bodies to detect particulate matter. The microscopic particle filter paper analysis is done with the filter assembly for retaining particulate matter, which consists of a filter holder typically made of glass and equipped with a vacuum source and a suitable membrane filter.

The sample is placed on the filter paper and observed under a microscope. Next, particulate matter is counted to obtain total particulate matter count. Further, the particulate matter is identified and classified based on its shape and size, and the results are compared to the acceptable limits.

The filter paper analysis is integral to the quality control process for injectable, ophthalmic, and MDI products. This analysis helps to identify and quantify any particulate matter that may be present in the determined particulate matter count test.

Companies like TSI Incorporated, Beckman Coulter, Met One Instrument, PAMAS, and more. However, observing and analyzing the result can be a backbreaking process in the pharma industry. ImageProVision offers solutions to calculate the amount of particulate matter in parenteral drugs. 

ImageProVision Solutions

ImageProVision offers ipvPCount, a semi-automatic software, and ipvAutoCount, a fully automatic software generating reports according to the USP general chapters <788>, <789>, <790>, and <1788> protocols.

IpvPCount

ipvPCount is a one-stop consisting of a high-resolution camera and software complaint with 21 CFR Part 11 that can seamlessly integrate with any microscope. You can analyze pharma products like injectables, ophthalmic, MDI, and aerosol. ipvPCount allows filter paper analysis for both small- and large-volume injections. The system follows USP 788 and USP 789 for ophthalmic solutions. 

This simple, user-friendly interactive software helps new drug development and assists in FDA approval and ANDA filing. 

IpvAutoCount

ipvAutoCount is the advanced version of the ipvPCount with a trinocular microscope, a high-resolution camera integrated with 21 CFR Part 11 compliant software. With ipvAutoCount, automatic focusing and image capturing are possible with a high-end microscope.

In addition to the benefits rendered by ipvPCount, ipvAutoCount also helps in batch release while reducing manual efforts and time. 

Summary

As we end this blog, I hope you've gained valuable insights about microscopic particulate matter, counters, and their significance. 

Now is the moment to translate knowledge into action.

ImageProVision is here to help you automate the particulate matter counting for you. 

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Key Takeaways

• A microscopic particulate matter counter is an instrument that is utilized to measure and quantify tiny particles present in the air.

• It plays a vital role in pharmaceutical manufacturing by assuring the control and monitoring of particle contamination in cleanrooms.

• It helps maintain quality standards by witnessing and counting particles that have the potential to impact the purity of pharmaceutical products.

• It also enables compliance with regulatory prerequisites, such as Good Manufacturing Practice (GMP) guidelines.

• It's essential to assess and maintain the cleanliness of manufacturing environments so that contamination during drug production can be prevented. 

• Provides real-time data on particle levels, facilitating prompt corrective actions to uphold product quality and safety.

• Microscopic particulate matter counters contribute to the overall efficiency of pharmaceutical manufacturing methods by minimizing the risk of product deficiencies and assuring consistency in quality.