Quality inspection introduction

HWPFP pharmaceutical foil production inspection is suitable for bonding with polyvinyl chloride (PVC), polyvinylidene chloride (PVCD) and other hard sheets, and is used for aluminum foil for packaging of solid medicines (tablets, capsules, etc.). This product is coated with a protective layer and an adhesive layer.

The project details and standards of production testing are as follows:

【Appearance】Take an appropriate amount of this product (2m per roll, face up to the visual inspection in bright natural light. The surface should be clean, smooth, and evenly coated; the printing of characters and patterns should be correct, clear, and firm.

[Pinhole degree] Take ten pieces of samples with a length of 400mm and a width of 250mm (when the width is less than 250mm, take the width of the roll), and place them one by one on the pinhole inspection table (800mm×600mm×300mm or a wooden box of appropriate size, wooden Install a 30W fluorescent lamp in the box, put a glass plate on the wooden box, line the glass plate with black paper and leave a space of 400mm×250mm to check the sample
pinholes), check for pinholes in a dark place. There should be no dense, continuous and periodic pinholes: in each square meter, pinholes with a diameter greater than 0.3mm are not allowed; the number of pinholes with a diameter of 0.1.~0.3mm must not exceed 1. ,

[Barrier performance] Excessive water vapor is measured according to the water vapor transmission rate measurement method (YBB00092003-2015), the first method test condition B or the second method test condition B or the fourth method test condition 2. During the test, the heat cover faces the low humidity side, No more than 0.5g/(m²·24h).

[Heat sealing strength of the adhesive layer] Take two pieces of this product of 100mm×100mm, and take another 100mm×100mm polyvinyl chloride solid medicinal hard sheet (conforming to YBB00212005-2015) or polyvinyl chloride/polyvinylidene chloride solid medicinal compound hard
2 pieces (according to YBB00222005-2015). Lay the adhesive layer of the sample to the PVC side (or the PVDC side of the PVC/PVDC composite hard sheet). Put it in a heat sealer for heat sealing. The heat sealing conditions are: temperature 155°C±5°C, pressure 0.2Mpa, time 1 second. After heat sealing, take it out and let it cool. Cut it into a 15mm wide sample. Heat seal strength measurement method (YBB00122003-2015), the test speed is 200mm/min±200mm/min, the PVC (or PVDC) sheet is clamped on the upper clamp of the testing machine, and the aluminum foil is clamped on the lower clamp of the testing machine. Start the tensile testing machine to peel at an angle of 180°, and the average heat sealing strength shall not be lower than 7.0N/15mm (PVC); not lower than 6.0N/15mm (PVDC).

[Protective Layer Adhesiveness] Take a sample with a length of 90 mm in length and a full width (note that the sample should not have wrinkles). Place the sample flat on the glass plate with the protective layer up, take a piece of polyester adhesive tape (with a peeling force of not less than 2.94N/20mm from the aluminum foil), and press it evenly on the surface of the sample horizontally at a pressure of 160-180. Direction peels off quickly
There should be no obvious peeling off of the surface of the protective layer.

[Heat resistance of the protective layer] Take 3 pieces of this product of 100mm/100mm, respectively laminate the protective layer of the sample with the original aluminum foil, place it on a heat sealer, and heat seal it. Heat sealing conditions: temperature 200°C, pressure 0.2Mpa, time 1 second, take it out and let it cool to room temperature, separate the sample from the original aluminum foil, observe the heat resistance of the protective layer, there should be no obvious sticking on the protective surface.

[Adhesive cloth amount difference] Take 5 pieces of this product of 100mm×100mm, and weigh them accurately (m1), wipe off the adhesive with ethyl acetate or other solvents, and weigh them again (m2)
The difference between m1 and m2 is the coating amount of the adhesive. At the same time, calculate the average value of the coating amount of 5 smears. The difference between the coating of each piece and the average value should be within ±10.0%.

[Unwinding performance] Take 4 pieces of this product of 100mm×100mm, superimpose the sample adhesive layer and protective layer, place it on a flat plate of appropriate size, place a small flat plate of 20mm×20mm and a weight of 1.0kg on the sample in turn, After 2 hours in an oven at 40°C, take it out and observe that the adhesive layer and the protective layer cannot be bonded.

【Bursting Strength】Take 3 pieces of this product of 40mm×40mm, and put them on the bursting strength meter to measure them respectively, and all of them shall not be lower than 98kPa.

【Fluorescent substance】Take 5 pieces of this product with a size of 100mm×100mm and place them under ultraviolet light respectively, at 254nm and 365nm
Observed at the wavelength, the protective layer and the adhesive layer must not have flake fluorescence

[Volatile matter] Take 2 pieces of this product with a size of 100mm×100mm, accurately weigh them (ma), dry them at 130°C for 20 minutes, place them in a desiccator for 30 minutes, and then weigh them precisely (mb). The difference (ma-mb) shall not exceed 4mg.

【Dissolution test】Preparation of the test solution: take this product with an inner surface area of 300cm2, cut it into small pieces of 3 cm×0.3 cm, wash with water, dry at room temperature, put it in a 500ml Erlenmeyer flask, add 200ml of water, and use an appropriate method to After sealing, put it in a high-pressure steam sterilizer, keep it at 110±2°C for 30 minutes, let it cool down to room temperature, and use it as the test solution; take another water in the same way as the blank solution, and carry out the following tests: Precise measurement of easy oxides and water immersion solution 20ml, precisely add 20ml of potassium permanganate titration solution (0.002mol/L) and 1ml of dilute sulfuric acid, boil for 3 minutes, cool rapidly, add 0.1g of potassium iodide, place in the dark for 5 minutes, and use sodium thiosulfate solution (0.01 mol/L) titrated to near the end point, add 5 drops of starch indicator solution, continue to titrate until colorless, and take another blank solution in the same way, the difference between the consumption of sodium thiosulfate titration solution (0.01mol/L) should not exceed 1.5 ml. Heavy metals Accurately measure 40ml of the test solution, add 2ml of acetate buffer (pH3.5).

[Microbial limit] Take this product and press it on the inner layer with a sterile metal template with an opening area of 20cm2, slightly moisten the sterile cotton swab with sodium chloride injection, wipe it 5 times within the range of the plate hole, and replace it. Wipe 5 times with 1 cotton swab, wipe 10 times with 2 cotton swabs for each position, and wipe 100 cm2 of 5 positions in total. Cut off (or burn) each cotton swab immediately after wiping
Put it into an Erlenmeyer flask (or large test tube) filled with 30ml of sodium chloride injection. After wiping all the cotton swabs into the bottle, shake the bottle quickly for 1 minute to get the test solution. After the test solution is filtered by thin layer, it is inspected according to the law (“Chinese Pharmacopoeia” 2015 Edition Four General Rules 1105, 1106), the number of bacteria must not exceed 1000cfu/100 cm2, mold and yeast must not exceed 100cfu/100 cm2, large intestine Bacteria cannot be detected.

【Abnormal Toxicity】* Take 500 cm2 of this product, cut it into small pieces of 3 cm × 0.3 cm, add 50 ml of sodium chloride injection, put it in a high-pressure steam sterilizer, keep it at 110 ° C for 30 minutes, take it out, cool it for later use, and intravenously Injection, determined according to law (Chinese Pharmacopoeia 2015 Edition Four General Rules 1141), should meet the regulations.

【Storage】 The inner packaging should be sealed in a low-density polyethylene bag, in a clean and ventilated place.
Attachment: Inspection Rules
1. Product inspection is divided into full item inspection and partial inspection.
2. In case of any of the following situations, all inspections shall be carried out according to the requirements of the standard.
(1) Product registration.
(2) Re-production of products after major quality accidents
(3) Supervision and random inspection.
(4) Resume production after the product is discontinued.
3. After the product is approved and registered, there will be no changes in the raw material origin, additives, production process, etc. of the pharmaceutical packaging material production and use enterprises