“IPQC Test for Parenterals: Common Tests and Their Significance”
What are Parenteral Dosage forms?
Parenteral dosage forms are medications that are administered through routes other than the digestive tract. This includes injections, infusions, and implantable drug delivery systems. The term “parenteral” is derived from the Greek words “para,” meaning beside or beyond, and “enteron,” meaning intestine.
Parenteral dosage forms are used when a medication cannot be given orally or when it needs to be rapidly absorbed and distributed throughout the body. This includes medications such as antibiotics, chemotherapy drugs, and vaccines.
Common types of parenteral dosage forms include intravenous (IV) injections, intramuscular (IM) injections, subcutaneous (SC) injections, and intradermal (ID) injections. These dosage forms can be administered by healthcare professionals or self-administered by patients who have been trained to do so.
Types of Parenterals
1. Based on types of packaging
a) Single dose units: ampoules, infusions and prefilled disposable syringes.
b) Multiple dose units: multiple dose vials.
2. Based on the production and control
a) Small volume parenterals: volume < 100 ml,
b) Large volume parenterals: volume ≥ 100 ml,
What are IPQC tests?
IPQC stands for In-Process Quality Control which refers to the monitoring of all processes used in the production of dosage forms, from the acquisition of raw materials through the delivery of the superior product in the best packaging.
It keeps an eye on all aspects of the product that can have an impact on its quality and guards against processing mistakes. These tests, which are carried out between QA and QC, allow for the authorization of authorized raw materials for manufacture based on actual laboratory testing, also known as IPQC, which includes physical, chemical, microbiologic, and biologic tests.
From the procurement of raw materials through the delivery of completed dosage forms, IPQC is concerned with giving precise, specific, and definite explanations of the methods to be used.
IPQC test for Parenterals>>
Leakage Test (visual inspection, bubble test, dye tests and vacuum ionisation test) The leakage test is used to ensure the package’s integrity. The integrity of a package reflects its “ability to keep the product inside while keeping potential contaminants out”.
It is because leakage occurs when there is a discontinuity in the wall of a package that allows gas under pressure or concentration differential to pass through. A dye bath test can be used to detect leakage.
Dye Bath Test–
A dye bath is used to immerse the test container. For a short period of time, vacuum and pressure are applied. The container is washed after being removed from the dye bath. The container is then visually or using UV spectroscopy inspected for the presence of dye.
The dye used could be blue, green, or yellowish-green. To increase capillary migration through the pores, a surfactant and/or a low viscosity fluid can be added to the dye solution. The dye test is widely used in industry and is approved for drug testing.
The test is cheap and does not require any special equipment for visual dye detection. However, the test is qualitative, destructive, and time-consuming. The test is used for ampoules and vials.
Clarity testing is used to determine the amount of particulate matter in a sample. In this test, transparent or white particles were observed against a black background, while black or dark particles were observed against a white background.
The purpose of the clarity test is to detect any visible particles, haze, or other visual abnormalities in the product that could affect its safety or efficacy. For example, the presence of visible particles in a parenteral product could indicate contamination or degradation of the product, and could potentially cause harm to the patient
The pH of the parenteral product is tested to ensure that it is within the specified range, as certain medications can be degraded or rendered inactive if the pH is outside of the acceptable range.
In pharmaceutical products, pH can affect the stability and effectiveness of the medication, as well as its compatibility with other medications or administration devices. For example, some medications may be more stable and effective at a specific pH, and deviations from that pH could affect their potency or stability. Additionally, some medications may cause irritation or tissue damage if they are administered at a pH that is too acidic or alkaline.
Particulate matter in injections
When inspected visually, preparations intended for parenteral use should be free of particulate matter and clear. According to the filled volume of the product to be tested, USP describes two methods. Filtration followed by microscopical examination is used for large volume parenterals (LVPs).
A light obscuration based sensor with an electronic liquid borne particle counter system is used for small volume parenterals (SVPs). If the LVPs under test contain NMT 50 particles per ml of 10 μm and NMT 5 particles per ml of 25 μm in an effective linear dimensional fashion, the USP standards are met. The USP standards are met if the SVPs under test contain NMT 10,000 particles per container of 10μm and NMT 1000 particles per container of 25 μm in an effective spherical diameter.
LIMITS FOR MICROSCOPIC PARTICLE COUNT TEST AS PER IP, USP, AND BP
|Volume of Solution||Particle Size ≥ 10 μm||Particle Size ≥ 25 μm|
|Large Volume Parenteral (LVP)||12 per ml||2 per ml|
|Small Volume Parenteral (SVP)||3000 per container||300 per container|
|Volume of Solution||Particle Size ≥ 10 μm||Particle Size ≥ 25 μm|
|Large Volume Parenteral (LVP)||25 per ml||3 per ml|
|Small Volume Parenteral (SVP)||6000 per container||600 per container|
Sterility is defined as the absence of viable microorganisms. It is performed to detect the presence of viable forms of bacteria, fungi, and yeast in parenteral products. To avoid accidental contamination of the product during the test, the sterility test must be performed under strict aseptic conditions.
All glassware used in the test must be sterile. The presence or absence of viable microorganisms in a sample number of containers taken from a batch of product is determined by sterility testing. The sterility of the batch is determined based on the results of the sample testing.
Sterility Test of Parenterals can be done by using Direct Inoculation Method or Membrane Filtration Method.
Container closure integrity testing
Container closure integrity testing is done to ensure that the container and closure system used to store the parenteral product are able to maintain the sterility of the product during its shelf life.
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