Sterility. Prior to entry, you must shower after being in a PCR building or wearing clothes that have been in a PCR building. The shower in the museum restroom is available for aDNA users. • Users must have dedicated aDNA lab clothing that must not have been worn in any post- PCR building. There is space in the museum molecular lab for clothing storage. • Users should not go from any organismal lab (mammal lab, bird lab, etc.) or collection range while wearing aDNA lab clothing. • Users must wear protective coverings, including lab coat, gloves, shoe covers (or dedicated lab shoes), hair net, and mask. These items can be re-used until determined to be in need of replacement. They should be stored in the lab entry, labeled with your name. User’s Initials Rev. 2015-11-06 kh • No clothing, gear, supplies, or equipment that has been in any post-PCR lab shall enter the aDNA lab. Leave your outerwear, laptops, backpacks, cloth watchbands, notebooks, badges, jump drives, etc. outside the lab, in the molecular lab or another lab. • Any supplies not already stocked in the lab can be brought in if it is newly purchased and delivered to the museum (primers, reagents, kits, etc.). Lab equipment will be brought into the lab by museum staff ONLY. • Work in the aDNA lab should be planned as the first thing in the day, to minimize contamination. • Users are expected to maintain clean, uncluttered counter and shelf spaces. Counters should be regularly cleaned with a 10% bleach solution followed with ethanol. Glassware or other instruments that have been washed and are drying should be put away in a timely fashion. ENTRY PROCEDURE • Get everything you need (specimens, supplies, etc.) prepared before showering and changing and stage it in the molecular lab space designated for the aDNA lab. • Shower and/or change into aDNA clothes in the museum and change into your dedicated aDNA lab clothing. • Enter the airlock, let the first door close. Put on the protective covering items; follow order posted in airlock. This is to include gloves, lab coat, shoe covers (or dedicated lab shoes), hair net, and mask. • At least 30 seconds must pass between the closure of the first door and opening of the second door – it will probably take at least that long to put on the lab coat, mask, etc.
Sterility. The final product, after reconstitution, should be sterile when examined by a suitable bacteriological method. Storage – Dried human plasma must be kept in atmosphere of nitrogen or in a vacuum in a sterile container sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at a temperature below 20° C.
Sterility. The final product should be sterile when examined by a suitable bacteriological method. Sodium content – The sodium content must not exceed 750 mg. per 100 ml. 25 % albumin solution. In the case of salt-poor albumin the sodium content must not exceed 325 mg. per 100 ml. 25 % solution.
Sterility. The final product should be sterile when examined by a suitable bacteriological method.
Sterility. The final product after reconstitution should be sterile, when examined by a suitable bacteriological method. Loss of weight on drying – When dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm. of mercury for 24 hours it must not lose more than 0.5 per cent of its weight. Storage – Human fibrinogen shall be kept in an atmosphere of nitrogen or in a vacuum in a sterile container sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at the temperature recommended.
Sterility. The determination as to whether each batch of a Biosurgery Product is Sterile by the procedures defined in the Biosurgery Product Specifications provides a small, but non-zero probability that each and every container of a Biosurgery Product produced as part of a batch of a Biosurgery Product, which batch is in compliance with the Biosurgery Product Specifications, is not Sterile. Biosurgery Product packaging and aseptic filling process has not been qualified by the Supplier to achieve or maintain a defined sterility assurance level. SUPPLIER DISCLAIMS ANY WARRANTY THAT EACH AND EVERY CONTAINER OF BIOSURGERY PRODUCT SHALL BE STERILE. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Sterility. Sterility test(USP <71> ; Ph. Eur. 2.6.1 Membrane filtration) Sterile
Sterility. To test for sterility of the hybridoma cell line, 1 ml of medium from the cultured cells should be collected sterilely and added sterilely to 500 ml bottle of Fluid Thyoglycollate Medium (VWR Catalog # BB4399112). The bottle should be incubated at 20o-25o C for 7 days. If the fluid is not turbid, the sample is sterile.
Sterility. The determination as to whether each batch of a Biosurgery Product is Sterile by the procedures defined in the Biosurgery Product Specifications provides a small, but non-zero probability that each and every container of a Biosurgery Product produced as part of a batch of a Biosurgery Product, which batch is in compliance with the Biosurgery Product Specifications, is not Sterile. Biosurgery Product packaging and aseptic filling process has not been qualified by the SUPPLIER to achieve or maintain a defined sterility assurance level. SUPPLIER DISCLAIMS ANY WARRANTY THAT EACH AND EVERY CONTAINER OF BIOSURGERY PRODUCT SHALL BE STERILE.
