1000mL Purillex PETG Square Media Bottle, Sterile, Case/24

1000mL Purillex PETG Square Media Bottle, Sterile, Case/24

Discover the versatility of the 1000mL Purillex PETG Square Media Bottle, designed for various life sciences applications such as buffer preparation and bulk drug substance handling. Crafted from durable and shatter-resistant PETG material, this bottle ensures long-lasting performance in demanding laboratory environments.

Benefit from its excellent gas barrier properties, which reduce permeability to CO2/O2, preserving the integrity of your samples. Molded-in graduations provide an approximate volume reference, facilitating accurate measurements.

This bottle features a unique lugged media bottle closure design (size 38-430) for a secure seal, offering seamless compatibility with other PETG media bottles in the market. Compliant with USP Class VI guidelines, it meets stringent quality standards.

Its inwardly sloped shoulders enable precisely controlled pouring, minimizing spillage and waste. Manufactured in the USA in our state-of-the-art, ISO Class 7 facility, this bottle upholds the highest standards of quality and production.

Product Features:

• Ideal for buffer preparation, bulk drug substance, and other life sciences applications
• Durable and shatter-resistant PETG material
• Excellent gas barrier properties
• Molded-in graduations for volume reference
• Compliant with USP Class VI guidelines
• Size 38-430 unique lugged closure design
• Inwardly sloped shoulders for precise pouring
• Made in the USA

Specifications:

• Material: PETG (Bottle), HDPE (Closure)
• Overflow (Brim) Capacity: 1200 mL
• A IN (MM): 8.75" (222.3)
• B IN (MM): 3.62" (91.9)
• C IN (MM): 1.72" (43.7)

CO2 Ingress Testing on Purillex® PETG Square Media Bottles

Carbon dioxide (CO2 ) ingress into polymeric containers can be an issue when storing or shipping pH-sensitive drug products, biologics, and other critical liquid materials. When storing or shipping these products, they can be packed in dry ice, which is the solid form of CO2 . Dry ice does not melt into a liquid, but rather sublimates from a solid to a gas, which has the potential to enter the container either through the bulk of the material or through the container/closure interface. If there is headspace in the container and CO2 gas enters, it has the potential to adversely affect the container contents by lowering the pH due to the formation of carbonic acid with container contents. Thanks to their lightweight, shatter-resistant nature, PETG (Polyethylene Terephthalate Glycol) bottles are an ideal option for scientists looking to avoid the issues that lead to CO2 ingress. They also boast exceptional gas barrier properties, making them an excellent choice for pharmaceutical and biologics manufacturing applications, including:

• Media and buffer storage
• Sample collection
• Buffer preparation
• Process intermediates
• Transportation of reagents

Testing was performed to determine if a pH shift could be measured in 1L Savillex Purillex PETG Square Media Bottles (both sterile and non-sterile) filled to nominal volume with phosphate buffered saline (PBS) after exposure to dry ice for a minimum of 60 hours. It is generally accepted that a pH shift of ±0.1 can be attributed to the freezing process itself. Any pH shift greater than 0.1 could indicate potential CO2 ingress. Based on the results of this test, no bottles from either group (dry ice or standard freezer) exhibited a pH shift greater than ±0.1, highlighting Purillex PETG Square Media Bottles as a robust container/closure system capable for use in dry ice storage or shipping applications.

Results and Discussion

A set of six (6) sterile and six (6) non-sterile 1L Purillex PETG Bottles from each of three (3) different manufacturing runs were sampled. The PBS solution pH was measured, the bottles were filled to nominal volume, and the closures were torqued to 30 in-lb (Savillex recommended torque value). All bottles were placed in an upright freezer at -85°C for a minimum of 48 hours. After 48 hours, three (3) sterile and three (3) non-sterile bottles from each of the three (3) different manufacturing runs were transferred to a bunker containing dry ice for a minimum of 60 hours (Figures 1 and 2). The bottles were then removed from the freezer and dry ice bunker and allowed to thaw for a minimum of 120 hours prior to measuring pH. Figure 1: 1L Purillex PETG Bottless in upright freezer at -85°C (control bottles) In addition to the 1L bottles tested, six (6) 250 mL bottles were used as positive controls. A 1/8” hole was drilled in the closures, and all bottles were placed in the upright freezer at -85°C for a minimum of 48 hours. Three (3) of the bottles were then placed in a bunker containing dry ice for a minimum of 48 hours to ensure Figure 2: 1L Purillex PETG Bottles packed in dry ice (note that only bottle closures can be seen in the image) exposure to CO2 gas. The bottles were then removed from the freezer and dry ice bunker and allowed to thaw for a minimum of 120 hours prior to measuring pH. After 120 hours, bottles were removed from the dry ice bunker, and the control bottles from the upright -85°C freezer and allowed to thaw to room temperature at which time f inal pH measurements were recorded. See Tables 1 and 2 for test results from both 1L bottle groups, and Tables 3 and 4 for positive control results.

Based on the results of this test, no bottles from either group (dry ice or standard freezer) exhibited a pH shift greater than ±0.1, highlighting Savillex Purillex PETG Square Media Bottles as a robust container/closure system capable for use in dry ice storage or shipping applications. Positive controls performed as expected, with the 250mL bottles with 1/8” hole in the closure and packed in dry ice exhibiting a significant drop in pH as compared to the other bottle groups (Figure 3). Positive control bottles in the -85°C freezer did not exhibit a drop in pH.

Download the Technical Notes on Performance Testing for Purillex PETG Media Bottles