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Updated: Jul 14

Technical Review Article | Open Access | Published 11th of July 2025

Recent Advancements Of Microbiological Testing Of Intrauterine Contraceptive Devices


Prerna Chaturvedi1, Akanksha Dwivedi2, Sweta S. Koka2, Pravin Kumar Sharma2 and Sumeet Dwivedi2*  1Chameli Devi Institute of Pharmacy, Indore & 2Acropolis Institute of Pharmaceutical Education and Research, Indore. EJPPS | 302 (2025) | https://doi.org/10.37521/ejpps30213

Abstract 

Microbiological analysis is a critical process to ensure the safety, efficacy, and quality of medicines and other health-related products. This analysis identifies and controls the presence of microorganisms that could compromise the final product’s integrity and pose risks to patients’ health. The presence of microorganisms in products can lead to severe consequences, such as infections in patients, product degradation, and economic losses for companies. International regulations, including Good Manufacturing Practices (GMP) and official pharmacopeias, set stringent requirements for microbiological analysis. This type of analysis is especially vital for sterile products like injectables and eye drops, where any contamination could pose significant risks. It also applies to non-sterile products, such as creams, tablets, and syrups and any medical devices to ensure microbial loads remain within acceptable limits. Intrauterine devices (IUDs) are small, reversible birth control devices inserted into the uterus to prevent pregnancy, with two main types: copper IUDs and hormonal IUDs, both highly effective and lasting for several years. Microbiological testing of intrauterine contraceptive devices (IUDs) is crucial to assess the risk of infection, particularly pelvic inflammatory disease (PID), and to identify potential pathogens associated with IUD use, with studies showing that IUDs can harbor biofilms and various microorganisms. The present review focused on the importance and advancements of Microbiological testing of intrauterine contraceptive devices. Also, various methods employed for the microbiological testing of IUD have been highlighted in this paper.

 

Key-words: Microbiological Testing, Intrauterine, Contraceptive devices


Introduction

Contraceptive Devices 

Contraceptive devices are medical instruments designed to prevent pregnancy by acting as physical or chemical barriers, altering hormonal balance, or preventing sperm from reaching the egg. They offer various options for individuals seeking birth control, with choices based on effectiveness, convenience, and personal preference.  Contraceptive devices provide diverse options for pregnancy prevention, ranging from temporary to permanent solutions. Ongoing research continues to improve their effectiveness, convenience, and safety [1]. There are several types of contraceptive devices. Some of these are listed below.[2]

Barrier Methods: These devices physically block sperm from reaching the egg.

  • Male Condoms: A sheath worn over the penis; made of latex, polyurethane, or polyisoprene.

  • Female Condoms: A pouch inserted into the vagina before intercourse.

  • Diaphragms: Dome-shaped devices placed over the cervix; used with spermicide.

  • Cervical Caps: Smaller than diaphragms, covering the cervix to prevent sperm entry.

  • Spermicides: Chemical agents (gels, foams, suppositories) that kill or immobilize sperm.

 Intrauterine Devices (IUDs): Inserted into the uterus to prevent fertilization.

  • Copper IUDs (Non-hormonal): Release copper ions, toxic to sperm.

  • Hormonal IUDs: Release progestin to thicken cervical mucus and suppress ovulation (e.g., Mirena, Kyleena).

Hormonal Contraceptives (Implants and Patches)

  • Contraceptive Implants: A small rod inserted under the skin that releases hormones (e.g., Nexplanon).

  • Contraceptive Patch: A skin patch that releases estrogen and progestin.

Vaginal Rings: Flexible rings inserted into the vagina (e.g., NuvaRing), releasing hormones to prevent ovulation.

Permanent Contraceptive Devices: For individuals who seek a long-term solution.

  • Tubal Ligation Clips/Rings: Used to close fallopian tubes surgically.

  • Vasectomy Clips: Used in male sterilization procedures to block sperm transport.

 

 

Intrauterine Contraceptive Devices (IUCDs): IUCDs are small, T-shaped devices inserted into the uterus to provide long-term contraception. They are safe, effective, and reversible, making them a popular choice for many individuals seeking birth control. IUCDs offer a highly effective, long-term contraception option for individuals seeking convenience and reliability. Choosing between a copper and hormonal IUCD depends on personal preferences, health conditions, and sensitivity to hormones. Both hormonal and copper IUDs offer different mechanisms of action, with the choice of type often based on individual preferences and medical needs. [3-4] 


Fig. 1: Various types of IUCDs [5]
Fig. 1: Various types of IUCDs [5]

Microbiological Testing: Microbiological testing involves the detection, identification, and quantification of microorganisms such as bacteria, viruses, fungi, and parasites in each sample. It plays a crucial role in public health, food safety, pharmaceuticals, water quality, and clinical diagnostics [6-7]. The principal goals of testing are:

  • To ensure safety and quality of products (e.g., food, water, drugs)

  • Diagnosis of infections in clinical settings

  • To monitor environmental contamination

  • To validate sterility in pharmaceutical and medical devices

 

Need for Microbial Testing of IUCDs: Microbial testing of Intrauterine Contraceptive Devices (IUCDs) is essential to ensure they are safe, sterile, and free from harmful microorganisms before being used in the human body. Microbial testing of IUCDs is a critical quality assurance step that protects patients, ensures product efficacy, and meets strict regulatory standards. It supports the safe use of these long-term contraceptive devices in clinical practice [8-9]. The main reasons for microbial testing of IUCDs are described below:

  • Patient Safety: IUCDs are inserted directly into the uterus, a sterile environment. Any contamination can lead to serious infections such as pelvic inflammatory disease (PID) or endometritis.

  • Sterility Assurance: Microbial testing verifies that the IUCD is free from viable microorganisms, ensuring compliance with sterility standards required for Class II or III medical devices

  • Regulatory Compliance: Required by agencies such as the FDA, WHO, and ISO standards (e.g., ISO 11737) for medical device sterility testing.

  • Quality Control: Ensures batch-to-batch consistency in manufacturing and detects any contamination during production or packaging.

  • Prevention of Biofilm Formation: Some microorganisms can form biofilms on device surfaces, which are harder to eliminate and can cause chronic infections. Early detection prevents such risks.

 

Microbiological Testing of Intrauterine Contraceptive Devices (IUCDs): Microbiological testing of intrauterine contraceptive devices (IUCDs) is essential to ensure they are free from microbial contamination, safe for human use, and meet regulatory standards. Since IUDs are implanted directly into the uterus, sterility and biocompatibility are crucial to prevent infections and complications. Further, in-use monitoring of IUCDs involves checking for bacterial contamination, particularly after insertion, to assess the risk of pelvic inflammatory disease (PID) or other infections. While most IUCDs are safe and effective, some studies have found that removed IUDs can carry bacteria, often common uterine flora, but these are not necessarily linked to PID. The primary goal of microbiological testing is to assess the risk of infection associated with IUCD use. This is especially important in cases where women experience symptoms of pelvic infection. Bacterial cultures are the most common type of microbiological test performed on IUDs. These tests can identify specific types of bacteria that may be present on the device. Positive cultures may indicate the presence of bacteria, but they don't always mean the user has an infection. Most IUDs are safe and effective, and the bacteria found on them are often normal uterine flora [10-12]. There are several other methods for the microbial testing of IUCDs which are mentioned below [13-14]:

Sterility Testing

  • Ensures that IUDs are free from viable microorganisms.

  • Conducted as per pharmacopeial guidelines (USP <71>, EP 2.6.1, or ISO 11737-2).

  • Methods:

    • Membrane Filtration: Suitable for liquid-coated or small components of IUDs.

    • Direct Inoculation: Used for solid or non-filterable components, incubating them in culture media to detect microbial growth.

Bioburden Testing

  • Determines the total microbial load on the device before sterilization.

  • Conducted following ISO 11737-1 standards.

  • Methods include:

    • Plate count techniques.

    • ATP bioluminescence assays for rapid detection.

    • Microbial identification to assess contamination sources.

Bacterial Endotoxin Testing (BET) / Pyrogen Testing

  • Detects bacterial endotoxins from Gram-negative bacteria, which can cause severe inflammatory reactions.

  • Methods:

    • Limulus Amebocyte Lysate (LAL) Test (Gel-clot, Turbidimetric, and Chromogenic) (Fig.1).

    • Recombinant Factor C (rFC) Assay as an alternative to LAL (Fig.1).

    • Antimicrobial Effectiveness Testing (AET)

      • Assesses the efficacy of antimicrobial coatings on IUDs to prevent infections.

      • Involves inoculating the device with known pathogens and monitoring microbial reduction over time.

Environmental Monitoring in IUD Manufacturing

  • Ensures aseptic conditions in cleanrooms where IUDs are manufactured.

  • Includes:

    • Air sampling (active and passive methods).

    • Surface monitoring (swabs and contact plates).

    • Personnel hygiene monitoring (glove and gown testing).

Fig. 1: Microbial testing detail of LAL and rFC
Fig. 1: Microbial testing detail of LAL and rFC

Recent Advancements in Microbiological Testing for IUCDs: Advancements in microbiological testing have significantly enhanced the safety and sterility assurance of Intrauterine Devices (IUDs). These innovations aim to improve detection speed, sensitivity, and specificity in identifying microbial contamination. These recent innovations have strengthened microbiological testing for IUDs, ensuring faster, more accurate, and regulatory-compliant quality control. This ultimately enhances patient safety and product reliability in contraceptive care.

  • Molecular Diagnostic Techniques: Use of PCR (Polymerase Chain Reaction) and real-time PCR for rapid, sensitive detection of microbial DNA, allowing identification of low-level or non-culturable pathogens not easily detected by traditional methods.

  • Next-Generation Sequencing (NGS): This provides detailed microbial profiling of IUD surfaces. Also, it helps to detect emerging pathogens and to understand microbiome interactions post-insertion.

  • Rapid Sterility Testing: Encompassing new methods such as ATP bioluminescence and automated growth-based systems (e.g., BacT/ALERT) that reduce test time from 14 days to a few hours or days.

  • Endotoxin Detection Improvements: Including modern recombinant factor C (rFC) assays that are replacing traditional LAL tests, offering more ethical and consistent results.

  • Biosensor Technology: This requires the development of microbial biosensors for real-time contamination detection during production and packaging.

 

Conclusion

Microbiological testing of IUDs is vital for patient safety, ensuring these devices are sterile, free from harmful microorganisms, and compliant with regulatory standards. Advanced testing methods help improve the efficiency and reliability of quality control processes, reducing the risk of infections and complications associated with IUD use.

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Author Information


Authors: Prerna Chaturvedi1, Akanksha Dwivedi2, Sweta S. Koka2, Pravin Kumar Sharma2 and Sumeet Dwivedi2* 

1, Chameli Devi Institute of Pharmacy, Indore, Madhya Pradesh, India

2, Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, India


Corresponding Author: Sumeet Dwivedi,

Address: Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, India




 
 
 

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