Durability. Rub label with finger using moderate pressure. Text should not become smeared or illegible. 5. Label has sufficient overlap, but does not hide text. EXHIBIT EPI PEN PRODUCT SPECIFICATIONS Exhibit June, 1996 STI(R) PRODUCT SPECIFICATIONS EPIPEN(R) AUTO-INJECTOR -------------------------------------------------------------------------------- Epipen Epinephrine Injection 1:1,000; 0.3 mL/dose -------------------------------------------------------------------------------- POST 100% INSPECTION: Sampled per MIL-STD-105D Level II, Single Sampling, Normal Inspection TEST: VISUAL AUDIT (BASIC UNIT) TEST - CRITICAL DEFECTS LIMITS - AQL * Definition - Could, through use, present clear hazard to the user/patient. The product will not function as intended by delivering the specified dose, and therefore, causes misdiagnosis or subjects the user to significant risk. The fact that the product will not function is not clearly obvious prior to use. 1. Crack in glass (jeopardizes functionality or sterility). 2. Any visual indication of contamination/degradation of solution. 3. Hole or split in sheath, sheath missing or sheath penetrated by needle.
Appears in 2 contracts
Samples: Master Agreement (Dey Inc), Master Agreement (Dey Inc)
Durability. Rub label with finger using moderate pressure. Text should not become smeared or illegible.
5. Label has sufficient overlap, but does not hide text. EXHIBIT D EPI PEN PRODUCT SPECIFICATIONS Exhibit D June, 1996 STI(R) PRODUCT SPECIFICATIONS EPIPEN(R) AUTO-INJECTOR -------------------------------------------------------------------------------- ------------------------------------------------------------------------------ Epipen Epinephrine Injection 1:1,000; 0.3 mL/dose -------------------------------------------------------------------------------- ------------------------------------------------------------------------------ POST 100% INSPECTION: Sampled per MIL-STD-105D Level II, Single Sampling, Normal Inspection TEST: VISUAL AUDIT (BASIC UNIT) TEST - CRITICAL DEFECTS LIMITS - AQL * Definition - Could, through use, present clear hazard to the user/patient. The product will not function as intended by delivering the specified dose, and therefore, causes misdiagnosis or subjects the user to significant risk. The fact that the product will not function is not clearly obvious prior to use.
1. Crack in glass (jeopardizes functionality or sterility).
2. Any visual indication of contamination/degradation of solution. 3. Hole or split in sheath, sheath missing or sheath penetrated by needle.
Appears in 2 contracts
Samples: Master Agreement (Dey Inc), Master Agreement (Dey Inc)