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Quality Standard for Empty Aluminum Tubes with Screw Caps

This specification is applicable to aluminum tubes with screw caps (bouchons) used for ointment dispensing. The specification contains listed requirements for quality and storage conditions of aluminum tubes. The specification is developed in accordance with the requirements of the “Rules for organization of drug production and quality control, approved by the State Food and Drug Administration.

Name of parameters	Regulatory documentation requirements	Methods of analysis
Name	Aluminum tubes with screw caps (bouchons): - type B - type I
Regulatory document	BS 2006: 1984
Supplier	Tube plant, Leningradskaya region
Manufacturer	Tube plant, LLC, Kharkov TUBEKS, CJSC, Leningradskaya region
Sampling	In accordance with SOP – “Guideline for acceptance, sampling and quarantine of source and packaging materials”.
Income control	In accordance with requirements of BS 2006: 1984
Tubes dimensions	According to table and figure in Attachment A	BS 2006: 1984
Outer surface of tube:	The free edge of the tuba body shall be straightened, without torn or curved edges and compressed marks. Any aluminum burrs are not allowed in the tube neck.	Visual control
а) Enamel coating	A band completely or partially uncovered by enamel is allowed at a distance 1.0 ± 0.5 mm from the open end of the body.	Visual control
б) Printed text	According to the original layout	Visual control
в) Stability of enamel and printing inks to water	Shall be water resistant, shall not be washed and blurred.	BS 2006: 1984
г) Appearance of decorative coating	Decorative coating shall be clear. The following is allowed: - half-tint deviation of colors by a penton; - overlapping band at circular printing, width up to 2 mm; - misprints of area 0,3 mm², in quantity not more than one per a tube or 0,1 mm² n quantity not more than 3 per tube.	Visual control
Internal coating of tube	Shall be covered with a protective lacquer film. The coating shall be completely cured.	Visual control
а) Lacquer film	The surface shall be even, shiny. The following is allowed: - point inclusions of lacquer resin; - film thickening in certain areas of the internal coating; - dark points not more than 10 over area of 100 cm²; - A band completely or partially uncovered with lacquer is allowed up to 2 mm from the open end of the tube body.	Visual control
б) porosity of the lacquer film according to electrical device with electrolyte	Not more than 2 мА	BS 2006: 1984
	Not more than 25 мА	BS 2006: 1984
в) Resistance of lacquer coating	No bubbles and lacquer layer separation. (lacquer layer separation is allowed t along the tubу cut off line).	BS 2006: 1984
в) Resistance of lacquer coating	Uncoated places, stains and local lacquer burns are not allowed. Teardrop stains of lacquer are allowed at place of transition from the cylindrical part of the tube to the tapered shoulder, which can withstand the lacquer film flexibility test when bending.	BS 2006: 1984
г) Internal protective lacquer film thickness	0.005 ÷ 0.01 mm.	BS 2006: 1984
д) Latex sealing ring width	10±1 mm, at distance 2±1 mm from open edge of the tube.	Visual control
Latex sealing ring	Application of the sealant ring (Latex) inside the tube shall be uniform.	Visual control
Rigidity of the tube body:	d _tube 19 mm – from 8 to 12 mm d_tube 25 mm – from 8 to 13 mm	BS 2006: 1984
Rigidity of the tube body:	d _tube 19 mm – from 8 to 12 mm d _tube 25 mm – from 11 to 15 mm	BS 2006: 1984
Tightness of tube closure	The tube with the bushon screwed on it until tight shall be tight without fistulas and cuts, when the air pressure inside the tube is 0.05 MPa. For tubes with a membrane, the bushon shall ensure tightness of the tube when the membrane is punctured. The tube is supplied with compressed air at pressure of 0.25 bar during 3 seconds, there shall be no bubbles.	BS 2006: 1984
Allowed number of defective tubes	In accordance with the requirements BS 2006: 1984	BS 2006: 1984
Packaging	Tubes with screwed bushon shall be packed in boxes of corrugated cardboard or other containers that ensure safety of tube quality during transportation and storage. Tubes shall be laid with bushons down. Both bottom and top of the box of corrugated cardboard shall be covered with a polymer film to protect the tubes from contamination.