What is Sterility Testing?

Sterility Testing is a key procedure used to make sure that certain products, especially those used in medicine and pharmaceuticals, do not contain any live germs like bacteria or fungi. This test helps confirm that the product is completely free from contamination, which is essential to protect patient health and ensure the product works as intended. It is a required safety check for items such as injectable medicines, vaccines, surgical tools, implants, and other medical or biotech products. Without sterility testing, there would be a risk of infection or other serious health issues when using these products.

International Standards for Sterility Testing

International Standards for Sterility Testing, such as ISO 11737 and USP <71>, define validated methods to detect viable microorganisms in pharmaceutical or medical products. These ensure products are free from contamination, ensuring safety and regulatory compliance.

How is Sterility Testing Performed?

According to global pharmacopeias (USP, EP, JP), two validated methods are primarily used: Membrane Filtration and Direct Inoculation. Below is a scientific, step-by-step explanation of both methods based on validated industry practices, using the information inspired by Rocker Scientific’s sterility testing application (without copying content).

 1.Membrane Filtration Method

Membrane Filtration Method is ideal for Aqueous, alcohol-based, and clear liquid products that can be filtered without antimicrobial properties.

 Controlled Environment

Conducted in a Grade A laminar flow hood within a Grade B cleanroom.

All equipment (filtration system, forceps, culture media) must be sterilized via autoclaving or equivalent method.

 Sample Preparation

The product is diluted if necessary to reduce viscosity or antimicrobial effect.

A prescribed volume (e.g., 100 mL) is drawn aseptically.

 Membrane Filtration

The sample is passed through a sterile 0.45 µm membrane filter under vacuum or pressure.

The filter retains bacteria, fungi, and yeast.

Use separate filters for each type of culture media.

Membrane Transfer

After filtration, the membrane is aseptically transferred using sterile forceps to:

Fluid Thioglycollate Medium (FTM) – supports anaerobes and facultative bacteria.

Soybean Casein Digest Medium (SCDM or TSB) – supports aerobic and fungal growth.

 Incubation

FTM is incubated at 30–35°C, and SCDM at 20–25°C, for 14 days.

Visual inspection is performed periodically (typically every 2–3 days).

Interpretation

Any turbidity, sediment, or pellicle formation indicates microbial growth.

If growth is detected, identification of the organism is mandatory.

2. Direct Inoculation Method

Direct Inoculation Method is ideal for: Oily, viscous, or non-filterable products (e.g., creams, suspensions, ointments).

 Environmental Control

Testing must occur in Grade A/B sterile conditions with trained personnel and validated aseptic technique.

 Sample Preparation

The product is tested directly without filtration.

A specified quantity of the product is aseptically introduced into two types of media:

• FTM (Fluid Thioglycollate Medium)
• SCDM (Soybean Casein Digest Medium)

 Neutralization Consideration

If the product has antimicrobial activity, validated neutralizers or diluents are used to inactivate these effects.

Validation studies are often required to prove that microbial recovery is not inhibited.

 Incubation

Similar to membrane filtration:

• FTM: 30–35°C
• SCDM: 20–25°C
• Duration: 14 days

Monitoring

Monitor regularly for signs of contamination (turbidity, sediment, film).

Positive results require microbial identification and retesting.

Critical Controls for Both Methods

• Sterility assurance level (SAL): Must be ≤ 10⁻⁶ for terminally sterilized products.
• Environmental monitoring: Active/passive air sampling, surface swabs, personnel monitoring.
• Media validation (growth promotion test): Confirms that the media can support the growth of specified test organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus brasiliensis.
• Equipment (e.g., vacuum filtration units, manifold systems): Must be autoclavable and compatible with ISO standards.

 Summary Table

Both methods comply with:

• USP <71> Sterility Tests
• EP 2.6.1
• JP 4.06
• ISO 14644-1 & 2 (Cleanroom classification and monitoring)

Nikopharmed Sterility Testing Laboratory

Accreditation and Global Recognition

At International Nikopharmad Laboratory, our Sterility Testing services are backed by ISO/IEC 17025 certification and ILAC accreditation, ensuring full compliance with globally recognized standards of analytical quality and technical competence. These credentials affirm that our sterility testing data meet stringent international regulatory requirements and are accepted by health authorities worldwide.

Technical Excellence and Validated Infrastructure

Our facility is equipped with advanced, aseptically controlled environments including Grade A laminar airflow systems within Grade B cleanroom facilities, and we operate using validated ISO 11737-2 and USP <71> methodologies. Utilizing high-efficiency membrane filtration systems and direct inoculation protocols, we deliver accurate, reproducible assessments of microbial contamination. All procedures conform to ISO 10993-12 extraction protocols, simulating clinically relevant exposure conditions to ensure test realism and biological fidelity.

Regulatory-Ready Reporting and Timely Results

In an evolving regulatory landscape, rapid and reliable data delivery is critical. Our streamlined project management, rigorous quality assurance, and real-time sample tracking systems ensure fast turnaround times without sacrificing scientific accuracy. Each sterility test includes complete documentation with traceable raw data, growth promotion validation, statistical analysis, and submission-ready final reports, suitable for FDA, EMA, and global regulatory filings.

Confidentiality and Data Integrity

Client trust is central to our mission. All sterility testing activities are conducted under strict confidentiality agreements, safeguarded by 21 CFR Part 11–compliant electronic data systems. Our protocols ensure full data integrity, audit trail visibility, and ethical handling of all test materials—whether from pharmaceuticals, biologics, or medical devices.

Competitive Pricing with Uncompromised Quality

We understand the cost-sensitive nature of product development. That’s why we provide cost-effective sterility testing services tailored for startups, SMEs, and multinational manufacturers. Our pricing model is optimized to support your regulatory goals without compromising compliance, accuracy, or scientific rigor, helping you accelerate product approval timelines while protecting your investment.

 To request testing or a complimentary consultation contact Nikopharmad

Partner with Nikopharmad for Expert Sterility Testing

By choosing International Nikopharmad Laboratory as your sterility testing partner, you align with a globally accredited facility committed to scientific integrity, regulatory excellence, and client confidentiality. Whether you’re validating a novel medical device, biologic product, or parenteral drug, our sterility testing expertise ensures fast, reliable, and internationally accepted results—making us the strategic choice for developers aiming for efficient, compliant market access.