The factory inspection of pre-filled syringes is very i […]
The factory inspection of pre-filled syringes is very important in the inspection. The factory inspection standards are mainly composed of the following three parts.
1 Each batch of pre-filled syringe products can pass the inspection by the manufacturer's quality inspection department and can only be shipped out with a product certificate.
1.2 Ex-factory inspection items are inspected according to the requirements of appearance quality, tightness, lubricity and sterility. The inspection items include appearance quality and characteristic indexes.
1.3 According to the sampling plan for normal inspection in GB/T 2828.1-2012, the inspection items and the acceptance quality limit AQL level inspection level are shown in the following four inspection items.
Inspection item Inspection level Acceptance quality limit (AQL)
Appearance General inspection level I 0.65
Adhesiveness Special inspection level S-2 2.5
Lubricity General Inspection Level I 0.65
Sterility Special inspection level S-1 1.5
1.4 In the inspection results of pre-filled syringes, according to the counting sampling inspection procedure Part 1: The sampling plan for batch-by-batch inspection retrieved according to the acceptance quality limit (AQL)
(GB/T2828.1-2012) If the seal is judged to be unqualified, it is judged to be unqualified; if the other items are unqualified, double sampling is allowed
Re-inspect the unqualified items. If there are still unqualified items in the re-inspection, the batch of products will be judged as unqualified.
2 Supervision and inspection
During the supervision and inspection, the national quality supervision agency conducts the sampling inspection on the manufacturer according to the regulations.
3 Inspection lot
A certain number of pre-filled syringe products with the same nature, quality and same formula and produced in the same continuous production cycle are batched.
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