TECHNICAL INFORMATION
The bottles are manufactured in an ISO 13485 and ISO 9001 certified facility.
A continuously updated Validation Binder does assess all properties and technical information about the bottles.
Technical data sheets and other statements (extractables, leachables, compliance etc) are available upon request.
The square media bottles (# 56060, 56125, 56250, 56500, 56000) are produced with Polyethylene terephthalate(PET-Bottle) & High Density Polyethylene(HDPE-Cap) material which comply to USP class VI and 21 CFR § 177.1630.
The bottles are manufactured wholly from synthetic or manufactured materials and do not contain any raw material produced from, or substances derived of animal origin.
The manufacturing process does not use any ingredient of animal origin nor do the products come in contact with any animal products during storage and transportation.
The bottles are sterilized by e-Beam Radiation according to ISO 11137. They are Non-cytotoxic, Non-pyrogenic and RNase/Dnase/DNA free. A Certificate of Compliance is issued for each Lot of bottles.
WAREHOUSE
Single packages and entire pallets are shipped out of our Texas warehouse located 4 miles from DFW airport. Sea freight container loads can be delivered directly to our customers’ premises.
REGULATORY INFORMATION
According to CFR Title 21, Volume 8, Regulation 864.2240, the plastic bottles are considered a Class I Medical Device exempted from the premarket notification ( 510 (K) exempt) and also exempted from the GMP Regulation.
Precise information can be found under the Class I and Class II exempt devices listing in Part # 864, Group 864.2240, Product Code KJC:
“…a premarket notification application and fda clearance is not required before marketing the device in the U.S. …”
According to CFR Title 21, Volume 8, Regulation 807.65, manufacturers and initial importers are also exempted from an annual Device Registration and listing of the bottles:
„The following classes of persons are exempt from registration …:
…
(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.
…”
COMPATIBILITY AND INTENDED USE
The SPL bottles Cat no’s # 56000, 56500, 56250, 56125 and 56060 are intended for general laboratory and manufacturing use only. The bottles are not specifically validated for transportation of specimen and infectious or dangerous substances. They are destined for use in controlled environment (laboratory and manufacturing sites) by trained personnel only. End users may need to perform their own tests to determine further compatibility and suitability for applications beyond this intended use.
