All vials are sterile and pyrogen-free. Lot release sterility testing conforms to requirements set forth in USP <71>. Stopper and seal are not included.
Prior to serum bottle assembly, bottles are dry-heat sterilized and stoppers are steam-sterilized. The bottles /stoppers are assembled on an automated line located in a Class 100 suite. The serum bottles are subsequently capped in a Class 100,000 environment. Lot release sterility testing conforms to requirements set forth in USP <71>.
All vials are sterile and pyrogen-free. Lot release sterility testing conforms to requirements set forth in USP <71>. Stopper and seal are not included.
Prior to vial assembly, vials are dry-heat sterilized and stoppers are steam-sterilized. The vials/stoppers are assembled on an automated line located in a Class 100 suite. The vials are subsequently capped in a Class 100,000 environment. Lot release sterility testing conforms to requirements set forth in USP <71>.
