Testing Types
USP ⟨661.1⟩ Plastic Materials of Construction Testing

USP ⟨661.1⟩ Plastic Materials of Construction Testing

Comprehensive characterization of pharmaceutical packaging plastics to evaluate material identity, physicochemical properties, biological reactivity, and extractables risk, supporting packaging qualification and regulatory compliance.

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 ⟨661.1⟩ Plastic Materials of Construction?

USP ⟨661.1⟩ establishes the testing requirements for characterizing plastic materials intended for pharmaceutical packaging applications. At PLS Analytical, USP ⟨661.1⟩ studies help manufacturers evaluate the composition, physicochemical properties, and biological characteristics of packaging materials before they are incorporated into finished packaging systems.

What is USP ⟨661.1⟩ Testing?

PLS Analytical performs USP ⟨661.1⟩ testing to assess the identity, composition, physicochemical performance, biological reactivity, and other critical material attributes of pharmaceutical packaging plastics. These studies support material selection, supplier qualification, packaging development, change control, and regulatory submissions by generating the data required for informed packaging decisions.

Why it Matters

The performance of a pharmaceutical packaging system begins with the materials from which it is constructed. Insufficiently characterized plastics can increase the risk of compatibility issues, extractables and leachables, stability concerns, and regulatory challenges during development or commercialization.

PLS Analytical delivers USP ⟨661.1⟩ testing aligned with compendial requirements, helping manufacturers establish a strong scientific foundation for packaging qualification, strengthen material control strategies, and support compliant pharmaceutical packaging programs.

Testing Services

Build confidence in packaging materials before they become packaging risks

PLS Analytical performs USP ⟨661.1⟩ testing to support material qualification, packaging development, regulatory submissions, supplier evaluations, and lifecycle management activities.

Polymer Identification & Material Characterization

Polymer identification and material characterization evaluate the identity, composition, and fundamental properties of plastic materials used in pharmaceutical packaging. Scientifically robust data supports material qualification, packaging development, supplier evaluation, and informed packaging material selection.

Physicochemical Property Evaluation

Physicochemical property evaluation assesses the critical material attributes that influence pharmaceutical packaging performance. Scientifically robust data supports packaging development, material change evaluations, supplier qualification, and quality control programs.

Biological Reactivity & Safety Assessment

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

Additives & Extractables Risk Characterization

Additives and extractables risk characterization evaluates packaging additives, inorganic constituents, and potential extractable substances associated with pharmaceutical packaging materials. Scientifically robust data supports material screening, packaging qualification, extractables and leachables strategies, and risk assessment.

Advantages

Built for packaging qualification and regulatory readiness

USP ⟨661.1⟩ testing provides the foundational characterization data needed to evaluate plastic materials before they are incorporated into pharmaceutical packaging systems.

Improved Material Understanding

Comprehensive characterization establishes a clear understanding of material composition, performance attributes, and potential safety considerations.

Better Packaging Material Selection

Early-stage testing helps identify suitable materials before packaging system development and qualification activities begin.

Reduced Extractables & Leachables Risk

Material characterization supports risk assessments by identifying additives, extractable substances, and other attributes that may influence future packaging interactions.

Regulatory Compliance

USP ⟨661.1⟩ testing supports pharmaceutical packaging qualification programs by generating material characterization data aligned with USP requirements. The resulting documentation can support NDA, ANDA, IND, OTC, and global regulatory submissions, supplier qualification activities, change control programs, audits, inspections, and ongoing packaging lifecycle management.

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