T/CVDA 4-2019 Active Group standards

T/CVDA 4-2019 Animal liquid vaccine polyethylene bottle

Publish Date: 2019-12-18 Implement Date: 2020-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CVDA 4-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Packaging method

ICS Name: Laboratory medicine

Publish Date: 2019-12-18

Implement Date: 2020-05-01

Scope

Scope: This standard specifies the terminology, product classification, technical requirements, performance indicators, test methods, inspection rules, marking, packaging, transportation, and storage of polyethylene bottles for veterinary liquid vaccines. This standard applies to the packaging directly contacting veterinary liquid vaccines and diluents. This standard applies to plastic bottles made from polyethylene (PE) as the main raw material, using the injection-blow molding process, and may also be subject to high-temperature sterilization before filling. Main technical content: 5. Technical requirements 5.1 Raw materials: Polyethylene (PE). 5.2 Appearance quality: The appearance quality requirements shall comply with Table 1. Table 1: Appearance quality requirements Item Requirements Bottle mouth: The end face of the bottle mouth shall be flat, without chipping or missing parts, and there shall be no blocking or defects in the bottle mouth. Bottle body: The bottle body shall be fully molded, with uniform color and no obvious color difference. There shall be no sand holes, oil stains, bubbles, deformation, obvious shrinkage, or obvious scratches. Bottle bottom: The bottle shall be able to stand stably. 5.3 Performance indicators: The performance indicators shall comply with Table 2. Table 2: Performance indicators Item Requirements Identification: It shall be consistent with the control spectrum. Sealing: There shall be no water ingress or bubbling in the bottle. Resistance to falls: It shall not break. Water vapor permeability*: Not more than 0.2%. Residue of ignition*: Not more than 0.1% (residue of opacifiers in bottles shall not exceed 3.0%). Solubility test*: Clarity: The solution shall be clear; if it appears turbid, it shall not be more turbid than the standard solution No. 2. pH change: Not more than 1.0. Heavy metals: Not more than 0.001%. Oxidizable substances: Not more than 1.5ml. Non-volatile matter: Water shall