- How much sample is needed for the AET?
- What is the AET Validation? Why is it important?
- How do you handle organism identifications?
Child-Resistant Package Testing
- What is the failure level (f value)?
- What is the Certificate of Conformity?
- Are certificates needed for clinical trial packages?
- Is child-resistant packaging required for clinical trial?
- Can I use a child-resistant outer or secondary package?
- What is the Adult-Resecuring Effectiveness test
Do I need a Sample Submission Form?
As a requirement of our ISO 17025 accreditation, all samples being submitted must come with a sample submission form. Whether you use one of our forms or one of your own, the document must include the following information:
- Sample information (sample description, lot/batch/item #, etc.)
- Test(s) requested
- Contact information (name, company, address, phone/e-mail)
- Any other information that you would like to see on the report
Do I need a Purchase Order?
A Purchase Order number is required for all testing that has not been pre-paid. The PO number is part of the documentation that our QA Department reviews before they approve test reports for release. Results may be delayed for samples submitted without Purchase Orders if the PO number is not provided before testing is finished.
Many customers provide a “blanket PO” that covers testing up to a certain dollar amount or through a specified date. This makes the process of test ordering easier for the customer and eliminates delays in getting the results.
How much sample is needed for the AET?
Normally Perritt Laboratories uses 10mL (or 10 Grams) per organism per time point. For the standard USP test with 5 organisms plated at 14 & 28 days, we would use 100mL (10mL X 5 X 2). Validation requires 50mL. Total requested sample for the Standard Volume AET Validation and test = 150 mL.
There are times when it is not possible to test with the standard amount of product (availability may be limited, or it may be cost prohibitive). If you have such a product, please contact Perritt Laboratories to discuss how the AET can be performed using a smaller samples volume.
What is the AET Validation? Why is it important?
In the Antimicrobial Effectiveness Test, the laboratory evaluates a product’s antimicrobial effectiveness by comparing the number of specific test organisms in the product samples at specified time points. In order to get an accurate organism count, the lab must be able to neutralize the antimicrobial activity of the product and recover any of the test organisms that are still surviving in the product. The AET Validation (also called the Validation of Neutralization) demonstrates that the lab is able to do this.
The AET Validation is usually performed for each formulation.
Once the AET Validation has been performed on a particular formulation, an AET can be performed on subsequent samples of the exact same formulation without repeating the AET Validation.
How do you handle organism identifications?
When growth is observe in a sample, the number of colony forming units (cfu), or colonies are counted. The next step is to identify what organisms make up the colonies. We try to separate the colonies into distinct types and identify only one of each type. Our goal is to identify each different organism without identifying duplicates of the same organism.
Unfortunately, it is not always easy to be certain that each colony that we identify is different than the others. It is possible that more than one colony from one sample will ultimately be identified as the same organism. In addition, one colony may contain more than one organism.
Because each organism ID is performed individually, there is a separate charge for each one. One sample could require multiple organism identifications.
Child-Resistant Package Testing
What is the failure level (f value)?
According to 16 CFR Part 1700 (1700.20 ii), for unit dose packages , a failure is “the number of individual units which constitute the amount that may produce serious personal injury or serious illness”. This is based on a 25lb (11.4 kg) child. Keep in mind that toxicology is just one method of harm. Eye or skin irritation, flammability or other risks should also be considered.
Each company needs to decide what constitutes “serious personal injury or serious illness” for their product. For highly toxic or harmful products, the failure level is usually set at one (f = 1); access to one unit is considered a failure. For less toxic or harmful products, the failure level may be higher; a child could open some limited number of units.
The US test sets a default limit of “greater than eight”. This means that, unless a lower failure limit is declared, a failure occurs when a child gains access to a ninth unit.
What is the Certificate of Conformity?
The issue of package certification comes from the Consumer Product Safety Improvement Act of 2008 (CPSIA). If your package is subject to the PPPA requirements for special (child-resistant) packaging, you must issue a certificate stating that the package meets the applicable PPPA regulations.
The CPSC does not require a specific format for the certificate, but does provide guidance regarding the information that the certificate must contain. Electronic certificates are allowed.
Are certificates needed for clinical trial packages?
No, although clinical trial packaging usually needs to be child-resistant, certification of conformity for clinical trial packaging is not required.
Is child-resistant packaging required for clinical trial?
Yes, in most cases child-resistant packaging is required for clinical trial medications.
Can I use a child-resistant outer or secondary package?
The Poison Prevention Packaging Act (CFR 16 part 1700-1750) defines ‘package’ as the ‘immediate container or wrapper’. ‘Special packaging’ (commonly known as child-resistant packaging) is required to be this ‘immediate’ packaging. If there is an inner package containing the product that is placed in an outer package, the inner package must be the ‘special package’.
In general, a child resistant outer package containing non-child-resistant packages is not allowed. An exception might be granted by the US Consumer Product Safety Commission (CPSC) if the case is made that there are no other practicable means of packaging the product.
What is the Adult-Resecuring Effectiveness test?
CFR 16 Part 1700 includes testing for child resistance and senior-adult use effectiveness. While it is important that senior-adults be able to open the test package, it is also important that they be able to properly close the packages.
The Adult-Resecuring (senior re-securing) procedure was established specifically for reclosable packaging “where an objective determination (e.g., visual or mechanical) that a package is properly resecured cannot be made”. Push and turn closures are a good example of this type of closure.
In this test, packages are first tested on 100 senior-adults. The packages that the seniors opened, and apparently closed properly are then tested using 100 children. If children open too many of these packages, it may indicate that not enough senior adults were able to properly close the package.