Testing Types
USP ⟨87⟩ Biological Reactivity Tests, In Vitro

USP ⟨87⟩ Biological Reactivity Tests, In Vitro

In vitro cytotoxicity testing of pharmaceutical packaging materials to evaluate biological reactivity, support packaging qualification, and demonstrate biocompatibility for regulated drug products.

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 USP ⟨87⟩ Biological Reactivity Testing?

USP ⟨87⟩ Biological Reactivity Tests, In Vitro, establishes standardized cell culture methods for evaluating the cytotoxic potential of plastics, elastomers, and other polymeric materials used in pharmaceutical packaging. PLS Analytical performs USP ⟨87⟩ studies to help manufacturers assess the biological safety of packaging materials before they are incorporated into finished pharmaceutical packaging systems.

What is USP ⟨87⟩ Testing?

PLS Analytical performs USP ⟨87⟩ testing to evaluate the biological response of mammalian cell cultures following exposure to packaging materials or their extracts. Depending on the material and intended application, studies may include Agar Diffusion, Elution, or Direct Contact testing to determine cytotoxic potential and support material qualification, supplier evaluation, and regulatory submissions.

Why it Matters

Packaging materials must demonstrate biological compatibility before they are approved for pharmaceutical applications. Early identification of cytotoxic responses helps manufacturers reduce packaging qualification risks, strengthen material selection decisions, and support safer product development.

PLS Analytical delivers USP ⟨87⟩ testing aligned with compendial requirements, helping manufacturers generate scientifically defensible data for packaging qualification, biological risk assessments, and regulatory submissions.

Testing Services

Evaluate packaging material biocompatibility with confidence

PLS Analytical performs USP ⟨87⟩ testing to support packaging qualification, material characterization, supplier evaluations, regulatory submissions, and lifecycle quality management activities.

Agar Diffusion Testing

Agar diffusion testing evaluates the biological reactivity of packaging materials by assessing the effect of extractable substances on mammalian cell cultures. Scientifically robust data supports packaging qualification, elastomeric and polymeric material evaluations, cytotoxicity assessments, and biological safety studies.

Elution Testing

Elution testing evaluates the biological response of mammalian cell cultures to extracts prepared from pharmaceutical packaging materials. Scientifically robust data supports packaging qualification, extractables risk assessments, plastic and elastomeric material evaluations, and biological safety assessments.

Direct Contact Testing

Direct contact testing evaluates the biological reactivity of packaging materials through direct exposure of mammalian cell cultures to the test material. Scientifically robust data supports material characterization, packaging qualification, comparative material assessments, and development-stage packaging evaluations.

Advantages

Designed to support packaging safety and regulatory confidence

USP ⟨87⟩ testing provides critical biological safety data needed to evaluate pharmaceutical packaging materials before commercial use.

Early Identification of Biological Risks

Detects cytotoxic materials during qualification stages, helping prevent downstream packaging and product safety concerns.

Supports Material Selection Decisions

Provides objective biological response data that supports material screening, supplier qualification, and packaging development activities.

Strengthens Packaging Qualification Programs

Complements physicochemical characterization and extractables assessments by providing direct evidence of biological compatibility.

Regulatory Compliance

USP ⟨87⟩ testing supports pharmaceutical packaging qualification programs by generating biological reactivity data aligned with USP requirements. The resulting documentation can support NDA, ANDA, IND, OTC, and global regulatory submissions, packaging change controls, supplier qualification programs, inspections, audits, and ongoing lifecycle management activities.

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