Testing Types
Method Suitability Testing

Method Suitability Testing

Method suitability studies designed to verify that products do not interfere with microbial detection, supporting accurate, reliable, and compliant microbiological testing, keeping in mind the standards determined by USP<61>.

Terms and Conditions

I. Confidentiality:

PLS Analytical ("PLSA") maintains strict confidentiality with its clients.

Formal Confidentiality agreements may be initiated by the client or by PLS Analytical.

II. Financial Information

Payment in advance is required for clients whose credit has not been established with PLSA.
Payment terms are “NET 15 days from receipt of the results”. Buyer agrees to pay all costs, including, but not limited to attorney and accounting fees and other expenses of collection resulting from any default by buyer in any of the terms of this contract.
Purchase orders or valid credit card information are REQUIRED. Orders submitted without this information may cause delays in testing.
For third party billing a signed purchase order must be received from the party paying for the service.
A surcharge of 50% or greater will be added for EXPRESS service. Express is subject to prior approval and availability.
Pricing is designed for single samples. Project discounts may be available. Quotations will be provided free of charge.
A minimum billing of $25.00 will be charged on all samples including those samples cancelled at the customer's request.
Clients that request Raw Data will have a copy sent to them electronically (at no charge) along with their report. There may be a surcharge for copies of the raw data and report when requested after initial sending is completed.
Additional charges may be assessed (e.g. hazardous samples, composite fee).
Shipping costs will be charged to clients that would like containers, coolers or ice packs returned.
Liability of PLSA is limited to an amount no greater than the amount invoiced.

III. Sample Submission:

Fill out the Sample Submission Form COMPLETELY, including product name, lot number, test, methods, and the amount of samples sent. Incomplete information may cause a delay in providing services.
All results will be reported by the method supplied and/or identified. If a limit is not supplied, we will default to associated compendia limits, or “Report Results” when compendial limits are not available.
All samples should be labelled with company name, product name and lot number. Samples received without a lot number will be sent back to the client for proper labeling. Hazardous Substances must be appropriately labeled for the protection of office and laboratory personnel.
- Shipping carton exterior must be labeled as to the hazard enclosed; caustic, cytotoxic, antineoplastic, explosive, corrosive, toxic, or carcinogenic, etc.
- Safety Data Sheet (SDS) must be provided for all Hazardous samples.
- Additional charges may be applied.
- Please place Sample Submission Form, SDS and any other correspondence submitted, in an envelope and place at the top of the box or affixed to the outside of the box. Failure to use the PLSA Submission Form for Analytical Services may delay results.

IV. Retention and Disposal:

Samples are retained for a period of 30 days after completion of analysis.
Special PRIOR arrangements must be made to return or retain samples under other conditions.
Unless alternate arrangements have been made, raw data will be retained for 6 years after final report date.

IMPORTANT

Turnaround Times:
- In calculating turnaround times, pending all appropriate documentation is in order; if the sample is received before 10 am then the day the sample is received is Day 1 otherwise it will be on the next business day.
- Standard TAT is 10 Business days.
- Express Service is subject to prior approval, availability and surcharges.
- For International orders, please allow sufficient time for samples to clear customs.
Please pack samples appropriately to prevent breakage.
Because transportation of materials to our facilities can have significant impact on the moisture content of client sample materials, PLS Analytical will not accept client-provided Loss on Drying/Moisture content results. When required for testing, the Loss on Drying/Moisture Content will be performed at PLS Analytical and will be billed to clients at a flat rate. Please contact our Customer Service Team for current associated costs.
If growth is obtained during microbial enrichment testing, a gram stain will be performed and billed to the client. Please contact our Customer Service Team for current associated costs.
For Questions regarding the above information please contact our Client Services Department at 732-698-5050.

I confirm that I have read and accept the terms and conditions.

Sample Submission Form

Submitter Information

Date

Company Name / Address

Contact Name

Billing

Send Invoice To

If differentSame as Report

Name and email for invoicing

Order References

PO Number*

Quote Number*

Turn Around Time

StandardRush

Express, needed byInclude Raw Data

Controlled substance

Yes No

Microbiology sample suitability

YesNo

Analytical sample: method verification required

YesNo

Special Instructions

Fill The Sample Columns

SAMPLE NAME	LOT # (ONE LOT PER LINE)	METHOD (MUST BE PROVIDED)	TEST REQUESTED (MUST BE PROVIDED)	SPECIFICATION (MUST BE PROVIDED)	QUANTITY

Required for Testing to Begin Customer Initials and Date

Overview

What is Method Suitability?

Method suitability is a microbiological assessment performed to confirm that a product does not interfere with the recovery or detection of microorganisms during testing. At PLS Analytical, these studies help manufacturers demonstrate that microbiological methods are appropriate for their specific formulations, supporting accurate and reliable test results.

What is Method Suitability Testing?

PLS Analytical performs method suitability studies before sterility testing, microbial limit testing and other microbiological assays to verify that product characteristics do not compromise test performance. These evaluations establish confidence that selected methods can accurately detect microorganisms under the intended testing conditions.

Why it Matters

Product formulations containing preservatives, antimicrobial ingredients, or complex excipients can inhibit microbial recovery and lead to false-negative results if not properly assessed. Method suitability testing helps manufacturers reduce testing risks, and generate scientifically defensible microbiological data.

PLS Analytical delivers method suitability studies aligned with USP requirements and global regulatory expectations, helping manufacturers support product release, regulatory submissions, and ongoing quality assurance with confidence.

Testing Services

Demonstrating method performance for reliable microbiological testing

Method suitability studies are designed to evaluate potential product interference and confirm that microbiological methods can accurately recover and detect microorganisms under defined testing conditions.

1. Sterility Test Method Suitability

Sterility test method suitability evaluates product-specific inhibitory properties to confirm reliable microorganism recovery in accordance with USP requirements. Scientifically robust data supports sterile pharmaceutical products, injectables, biologics, medical devices, and regulatory compliance.

2. Microbial Limit Test Method Suitability

Microbial limit test method suitability evaluates product interference during microbial enumeration and specified organism testing. Scientifically robust data supports non-sterile pharmaceutical products, OTC products, dietary supplements, and reliable microbial recovery.

3. Bacteriostasis & Fungistasis Studies

Bacteriostasis and fungistasis studies evaluate whether a product inhibits the growth of microorganisms used during microbiological testing. Scientifically robust data supports preserved formulations, antimicrobial products, complex formulations, and method suitability assessments.

4. Neutralization & Recovery Verification

Neutralization and recovery verification evaluates the effectiveness of neutralization techniques and recovery procedures for challenging product matrices. Scientifically robust data supports preservative-containing products, antimicrobial formulations, microbiological method suitability, and regulatory compliance.

5. Product-Specific Method Evaluation

Product-specific method evaluation assesses microbiological method suitability based on individual product formulations, manufacturing processes, and testing requirements. Scientifically robust data supports new product introductions, reformulated products, process changes, and routine microbiological testing programs.

Advantages

Built for reliable, compliant microbiological testing

Method suitability studies help reduce testing risk| improve data reliability, and support regulatory confidence by demonstrating that microbiological methods perform as intended for each product.

Reliable Microbial Recovery

Confirms that microorganisms can be detected and recovered in the presence of the product, reducing the risk of false-negative results.

Product-Specific Validation

Suitability studies are performed for individual formulations to address product-specific characteristics that may impact test performance.

Regulatory Compliance

Supports USP and regulatory expectations by providing documented evidence that microbiological methods are appropriate for their intended use.

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