Testing Types
USP ⟨661.2⟩ Plastic Packaging Systems for Pharmaceutical Use Testing

USP ⟨661.2⟩ Plastic Packaging Systems for Pharmaceutical Use Testing

Comprehensive qualification of pharmaceutical packaging systems to evaluate safety, extractables risk, physicochemical performance, and drug product compatibility.

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 ⟨661.2⟩ Plastic Packaging Systems for Pharmaceutical Use?

USP ⟨661.2⟩ establishes the testing framework for evaluating finished plastic packaging systems intended for pharmaceutical use. Unlike USP ⟨661.1⟩, which focuses on individual plastic materials, USP ⟨661.2⟩ assesses the complete packaging system to determine its suitability for protecting pharmaceutical products throughout their intended use. PLS Analytical performs these studies to help manufacturers qualify packaging systems with confidence.

What is USP ⟨661.2⟩ Testing?

PLS Analytical performs USP ⟨661.2⟩ testing to evaluate the physicochemical characteristics, biological reactivity, extractables profile, and compatibility of finished plastic packaging systems. The resulting data supports packaging qualification, product development, risk assessments, and regulatory submissions by demonstrating that packaging systems are suitable for their intended pharmaceutical application.

Why it Matters

The performance of a finished packaging system depends not only on its individual materials but also on how those components function together. Manufacturing processes, additives, and system assembly can influence packaging performance and introduce compatibility or extractables-related risks that may affect product integrity.

PLS Analytical delivers USP ⟨661.2⟩ testing aligned with compendial requirements, helping manufacturers strengthen packaging qualification strategies, support USP ⟨1663⟩ and USP ⟨1664⟩ studies, and generate reliable data for regulatory submissions and long-term product quality.

Testing Services

Establish packaging system suitability before it becomes a regulatory concern

PLS Analytical performs USP ⟨661.2⟩ testing to support packaging qualification, extractables assessments, compatibility studies, regulatory submissions, and lifecycle management programs.

Physicochemical Characterization

Physicochemical characterization evaluates the fundamental properties of finished pharmaceutical packaging systems. Scientifically robust data supports packaging qualification, product development, quality assessments, and regulatory submissions through physicochemical testing, Total Organic Carbon (TOC) analysis, and extractable organic content evaluation.

Biological Reactivity Assessment

Biological reactivity assessment evaluates the biological characteristics of finished packaging systems intended for pharmaceutical applications. Scientifically robust data supports packaging safety assessments, packaging qualification, parenteral applications, high-risk dosage forms, and regulatory submissions.

Extractables Evaluation

Extractables evaluation characterizes substances that may migrate from pharmaceutical packaging systems under controlled extraction conditions. Scientifically robust data supports packaging qualification, product development, extractables and leachables strategies, risk assessments, and regulatory submissions.

Packaging System Qualification & Compatibility Support

Packaging system qualification and compatibility support evaluates the suitability of pharmaceutical packaging systems for their intended application. Scientifically robust data supports packaging qualification, compatibility assessments, packaging changes, supplier transitions, new product development, and lifecycle management.

Advantages

Built for packaging qualification and regulatory confidence

USP ⟨661.2⟩ testing generates the data required to demonstrate that packaging systems are suitable for pharmaceutical use and compatible with product quality objectives.

Improved Packaging System Understanding

Provides insight into how finished packaging systems behave under pharmaceutical use conditions.

Early Identification of Extractables Risk

Detects packaging-derived substances before they become stability, compatibility, or regulatory concerns.

Stronger Regulatory Readiness

Generates scientifically defensible data aligned with USP packaging qualification expectations and extractables assessment strategies.

Supports Product Safety & Lifecycle Management

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