Thank you for your inquiry for services performed by C.G. Laboratories. We realize that time is precious, and we respect your time. We have discovered with our years of experience that we can save you time if you would complete this Customer Intake Form. Once completed, we will be able to provide a quotation for the services you require. There is a possibility we will need additional information. Thank you very much for your cooperation and if you have any questions, do not hesitate to contact your Customer Service Representative.

SECTION 1

Customer Contact Information

Customer Contact Date
Company Name
Email Address
Contact
Phone Number
How did you hear about CG Laboratories? (Check all that apply)

Customer Billing Information

Company Name
Email Address
Address
City/State/Zip
A/P
Phone Number
Email Invoices
PO Required for Testing?
Preferred Freight Company?
Freight Account No.

General Questions

NDA Required?
Service Requested
Turn-Around-Time Needed
Comments

SECTION 2: AGING STUDY TESTING

CGL Issued Protocol
Device (Product) Type
Device Size
Aging Temperature(s)
Length of Aging Study (years)
No. Pull Points
CGL Testing Performed at each pull point
Customer Testing Performed at each pull point
No. Samples per test, per pull point
Preferred Shipping Method (Customer Testing)

SECTION 3: BIOBURDEN TESTING

Device (Product) Type
Device Size
Testing Condition(s)
No. of samples to be tested
Samples to be split between multiple conditions or tested individually?
Anti-Microbial / Preservatives in Product?
Specifications?
Quote Bioburden Recovery Testing?
Quote for Identification on top 3-Predominant Organisms?

SECTION 4: CLEANING VALIDATION, PROCESS

Type of Validation
If applicable
No. Product Types
Product Description
Product Size
Cleaning
No. of Cleaning Steps
No. of Organisms
No. Product Replicates
No. Positive Controls:
No. Negative Controls:

SECTION 5: CLEANING / DISINFECTION VALIDATION, REUSABLE DEVICE

Type of Validation
If applicable
No. Device Types
Device Description
Device Size
Pictures of Device Box
Can the device be fully submerged?
Cleaning Method
Cleaning
No. of Cleaning Steps

(included in cleaning instructions)

Level of Disinfection
No. of Organisms
No. Devices Replicates
No. Runs
No. Positive Controls
No. Negative Controls

SECTION 6: DISINFECTION VALIDATION, SURFACE (CLEANROOM)

Type of Validation
No. Surface Types
No. of Disinfectants
Description of Disinfectants
Cleaning

(included in cleaning instructions)

No. of Cleaning Steps

(included in cleaning instructions)

No. of Organisms
No. Sites
No. Runs
No. Positive Controls
No. Negative Controls

SECTION 7: DECONTAMINATION VALIDATION

Validation Method
Device Description
Device Size
Worst Case Locations

SECTION 8: DOSE DETERMINATION / QUARTERLY DOSE AUDIT TESTING

Device (Product) Type
Device Size
Bioburden Testing Condition(s)
Sterility Testing Condition(s)
Anti-Microbial / Preservatives in Product?
Quote for Identification on top 3-Predominant Organisms?
QDA, current Verification Dose?
QDA, current Full Sterilization Dose?
Sterilization Type

SECTION 9: ENDOTOXIN (LAL) TESTING

Device (Product) Type
Device Size
Specifications
Method
Sterilization

SECTION 10: ENVIRONMENTAL TESTING

Clean Room?
ISO Class Clean Room
Clean Room Size
No. of Locations
Testing to be performed
Specifications

SECTION 11: EO RESIDUAL TESTING

Device (Product) Type
Device Category
Is the device a “Kit”?
Total No. of Pieces in “Kit”:
Additional Device Information

SECTION 12: PACKAGE INTEGRITY TESTING

Pouch Type
Pouch Dimensions
Total No. of Pouches
Testing to be performed
No. of Pouches to be tested, per test type
Testing Specification

SECTION 13: RESIDUAL MOISTURE

Device (Product) Type
Device Product Size
No. of samples to be tested
Testing Temperature

SECTION 14: STEAM STERILIZATION VALIDATION

Device (Product) Type
Surface area of the device
CGL written Protocol and Final Report?
Is this validation for a Product Family?
Product Family name, if applicable
Master Product (worst-case scenario) to be used for validation
How many devices will be tested in the validation?
Is the device fragile and are there areas of concern?
Are there any sharp areas of concern?
Is the device Single Use or Reusable?
Type of Cycle
Do you require Dry Time Verification? This testing determines or verifies the amount of time it takes to dry your device(s) after steam sterilization.
Do you have an IFU (Instructions For Use) that you want to validate? If yes, please attach.
Will the device be sterilized with a wrap or pouch?
Will the device be wrapped or pouched multiple times?
Cleaning Validation
Do you require a cleaning validation to demonstrate an effective cleaning method?
Do you have any special instructions?
Will the device require disassembly?
Do you want to include sonication for cleaning?
Do you require detergent or enzymatic blood removal?
Do you require Biocompatibility Testing after cleaning?
Biocompatibility Testing, Device Category
Biocompatibility Testing, Exposure Time
Reusable Validation
Do you require a multiple use validation?
Do you require testing after each cycle?

SECTION 15: STERILITY

Device (Product) Type
Device Product Size
No. of samples to be tested
Sterility Testing Conditions
Anti-Microbial / Preservatives in Product?

SECTION 16: STERILIZATION

Box. Dimensions
Total No. of Boxes
Sterilization Method
Sterilization Dose

SECTION 17: USP 61 / 62

Product Type
Product Size
Testing Condition(s)
No. of samples to be tested
Anti-Microbial / Preservatives in Product?
Specifications?
Quote USP 62 Testing?
If no, disclaimer will be added to the Final Report

SECTION 18: Sealing Validation (OQ)

CGL Issued Protocol and Report *
Pouch Type
Testing to be Performed

Testing Specifications

SECTION 19: Sealing Validation (PQ)

CGL Issued Protocol and Report
Pouch Type
Testing to be Performed

Testing Specifications

customer intake form