BIOLOGICAL TESTING Clause Samples

BIOLOGICAL TESTING. 5.1 Sterility Testing Sterile products are dosimetrically released in accordance with SOP M-016, prior to final packaging. No routine sterility testing is performed on a lot-to-lot basis. 5.2 Endotoxin Testing (LAL) One (1) sample ≥ 0.5cc, representative of final product, shall be removed from each lot after sterilization and submitted to a qualified test laboratory for bacterial endotoxin testing via Limulus Amebocyte Lysate (LAL), gel clot or kinetic turbidimetric according to test method. Document sample removal on Form-118. Note: If more than one size, remove sample from smallest size. Specification: < 0.5 EU/mL In the event of failure, additional testing shall be performed. Test shall be performed on one sample in quadruplicate test tubes for LAL gel clot only.

BIOLOGICAL TESTING. As agreed to in your signed Relapse Prevention Agreement, you will participate in regular and randomly scheduled biological testing, which may occur any day of the week, Monday through Sunday. Your random biological testing is required to be completed at the designated collection site(s) as determined during your enrollment and in consultation with your monitor. At times, you may be requested to present for additional testing, either at a specified collection site or the office of Alliance Medical Monitoring Inc. These tests are at the discretion of the Alliance team and may be requested at any time when considered clinically necessary, including if there are reports of concerns within the workplace. Testing is typically administered through urinalysis; however, participants may be subject to testing using oral or other bodily fluids, breath or hair. All participants must maintain a minimum of one inch of body hair to facilitate hair testing if required. Where usual collection sites may be unavailable (such as on a weekend), you may be required to specifically attend for biological testing at the office of Alliance Medical Monitoring Inc. or at the collection location(s) of one of our private collectors. In the event that this is necessary and the collection site differs from the site(s) you typically attend, you will be advised by your monitor or another designate of Alliance Medical Monitoring Inc. It is your responsibility to determine your testing status daily. You will be notified through daily login to the portal accessed through the Alliance website: ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ or by using the Call-In notification system. Please note that failure to attend for biological testing as required because you failed to login or call in for testing status will result in a report of non-compliance. If you are due for testing, a standing order or requisition will have already been sent to the lab or collection site. For participants using LifeLabs, you must attend by 3:00pm, unless otherwise arranged by your monitor or another designate of Alliance Medical Monitoring Inc. In the event you attend a collection site that requires a specified appointment time, the time of your appointment will be reflected when you log into the online testing notification system. If you use the Call-In system and have not pre-arranged your appointment time(s), you will have to call your monitor or another designate of Alliance Medical Monitoring Inc. to determine your appoi...

BIOLOGICAL TESTING. The Mint will adhere to legislative health surveillance requirements for hazardous substances identified in schedule 2 of OHS (Safety Standard) Regulations 1994. Additionally, the Mint will undertake health surveillance measures for chemicals that have been identified as needing surveillance in a risk assessment and measured by a qualified person with calibrated instruments in scientific valid method.

BIOLOGICAL TESTING. The IDEXX Quanti-Tray® 2000 method was used to measure concentrations of Total Coliforms,