Products are washed with USP Water for Injection and handled post-washing in Class 5 clean rooms with Class 4 packaging/inspection hoods to produce these very low particulate products Certified and lot-to-lot tested to contain less than 1/3 the particulates allowable according to USP <788> to limit potential particulate contamination Certified low endotoxin (0.25 EU/mL) according to USP <85> to reduce pyrogens Sterile, ready-to-use products with a Sterility Assurance Level of 10 -6 inside the container/closure, including two heat-sealed sterile barriers to protect product prior to use Heat-sealed bags include quick-tears on the top and bottom and placed in carton liner twisted and tape/tie sealed to prevent gross contamination on the inner packaging All container/closure systems are certified leakproof* to protect valuable contents Robust, HDPE can be used from -100˚C to 120˚C, allowing for both heated mixing and frozen storage or shipment. Must be tested in actual use conditions as results may vary depending upon application. Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications Products can be supplied with forced extraction studies**, validation binders** and certificates Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support
Nalgene™ HDPE Platinum Certified Clean Bottles and Carboys
Our single-use products, including Thermo Scientific™ Nalgene™ HDPE Platinum Certified Clean Bottles and Carboys, help reduce the potential for carry-over contamination. Our new certified platinum clean products include particulate certifications to under 1/3 the allowable limits according to USP<788> and lower endotoxin levels of 0.25EU/mL, to help mitigate potential sources of unwanted impurities.
| Closure Material |
Polypropylene |
|---|---|
| No. per Case |
1, 72, 48, 24, 6, 4 |
| Shape |
Round |
| Autoclavable |
Not Autoclavable |
| Closure Included |
Yes |
| Certifications/Compliance |
< 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1315, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1324, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1323, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1322, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1320, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1321, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1319, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1318, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1317, < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1316 |
| Sterility |
Sterile |
| No. per Pack |
1, 12, 6 |
| Material |
HDPE |
| Closure Size |
83 mm, 20 mm, 24 mm, 43 mm, 53 mm, 28 mm, 38 mm, 63 mm |
| Color |
Colorless |
| Capacity (English) |
1115.9 oz., 1 oz., 8.5 oz., 16.9 oz., 33.8 oz., 338.1 oz., 676.3 oz. |
| Capacity (Metric) |
33 L, 30 mL, 250 mL, 500 mL, 1 L, 10 L, 20 L |
| Product Type |
Carboy, Bottle |
| Height (Metric) |
546 mm, 61 mm, 133 mm, 99.3 mm, 168.2 mm, 170.4 mm, 215.9 mm, 199.2 mm, 389 mm, 501.7 mm |
| Height (English) |
21.5 in., 2.4 in., 5.2 in., 3.9 in., 6.6 in., 6.7 in., 8.5 in., 7.8 in., 15.3 in., 19.8 in. |
| Diameter (Metric) |
381 mm, 34.3 mm, 61 mm, 72.6 mm, 91.4 mm, 250.2 mm, 284.2 mm |
| Unit Size |
Case of 1, Case of 72, Case of 48, Case of 24, Case of 6, Case of 4 |
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