Testing Types
Cleaning Validation Testing

Cleaning Validation Testing

Scientifically designed cleaning validation studies to verify equipment cleanliness, prevent cross-contamination, and support regulatory compliance across pharmaceutical manufacturing operations.

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 Cleaning Validation?

Cleaning validation is the documented process of demonstrating that manufacturing equipment can be consistently cleaned to remove product residues, cleaning agents, microbial contaminants, and other carryover materials. At PLS Analytical, cleaning validation studies help manufacturers establish scientifically justified cleaning procedures that support contamination control, product quality, and regulatory compliance.

What is Cleaning Validation Testing?

PLS Analytical performs analytical and microbiological cleaning validation studies to verify the effectiveness of pharmaceutical cleaning processes. Testing includes the evaluation of equipment surfaces for product residues, cleaning agents, microbial contamination, and other predefined contaminants against established acceptance criteria. These studies support facility qualification, equipment commissioning, process validation, product changeovers, and ongoing quality programs.

Why it Matters

Effective cleaning is essential for preventing cross-contamination and maintaining product quality in shared manufacturing environments. Inadequate cleaning can lead to batch failures, manufacturing disruptions, regulatory observations, and increased operational risk.

PLS Analytical delivers scientifically robust cleaning validation programs aligned with FDA, EMA, WHO, and global GMP expectations, helping manufacturers strengthen contamination control strategies, support regulatory inspections, and maintain confidence in routine manufacturing operations.

Testing Services

Verify cleaning effectiveness with confidence

PLS Analytical performs cleaning validation testing to support contamination control strategies, equipment qualification programs, process validation activities, and regulatory compliance requirements.

1. Residue Analysis Testing

Residue analysis testing evaluates equipment surfaces for residual active ingredients, excipients, cleaning agents, and process materials following cleaning procedures. Scientifically robust data supports shared manufacturing equipment, product changeovers, cleaning validation, contamination control, and regulatory compliance.

2. Swab & Rinse Sample Analysis

Swab and rinse sample analysis evaluates cleaning effectiveness through validated sampling of pharmaceutical manufacturing equipment. Scientifically robust data supports equipment qualification, cleaning process verification, routine monitoring, difficult-to-clean equipment assessments, and quality assurance.

3. Cleaning Validation Verification & Lifecycle Monitoring

Cleaning validation verification and lifecycle monitoring evaluate the continued effectiveness of validated cleaning procedures throughout routine manufacturing operations. Scientifically robust data supports commercial manufacturing, continuous process verification, quality system monitoring, deviation investigations, and lifecycle compliance.

Advantages

Built for reliable contamination control and regulatory readiness

Cleaning validation testing provides documented evidence that manufacturing equipment can be effectively cleaned and maintained in a state suitable for pharmaceutical production.

Reduced Cross-Contamination Risk

Validation studies help ensure that residual materials are removed to acceptable levels, reducing the risk of contamination between products, batches, and manufacturing campaigns.

Improved Process Consistency

Scientifically validated cleaning procedures support consistent manufacturing operations and help maintain product quality across routine production activities.

Enhanced Inspection Readiness

Comprehensive cleaning validation data demonstrates control of contamination risks and supports audit preparedness, regulatory inspections, and quality system requirements.

Loading...