复方过氧化物消毒液(无菌型) 复方过氧化物无菌消毒液 杀孢子剂
主要有效成分及含量 本品含过氧化氢1.3%~1.7%,过氧乙酸0.085%~0.115%。
杀灭微生物类别 可杀灭肠道致病菌、化脓性球菌、致病酵母菌和医院感染常见菌;可杀灭细菌芽孢。
使用范围
1.适用于一般物体表面消毒。
2.适用于医药工业洁净区A/B级环境。
使用方法
1.用于普通级别的区域的消毒:直接使用,喷雾、擦拭或者浸泡。
2.用于A/B/C级洁净区:因内包操作在B级区进行,所以内包内可无菌和无粒子,不会对洁净环境产生污染。所以应将产品连同内包装经紫外照射后,转移到洁净区后拆包使用。
3.物体表面消毒:将本品均匀喷雾于物体表面,使其保持湿润或擦拭物体表面1-2遍,作用≥5min。
4.浸泡消毒:将物品完全浸泡于本品中,作用≥10min。
联系电话:17856332777
邮箱:stephen.ching@caraee.com.cn
一、我们的优势:
- 经过0.22um过滤,确保不溶性微粒水平与注射剂要求相当;
- 经超滤去除细菌内毒素,确保不会对药品产生二次污染;
- B级洁净区进行内包操作,确保双层内无粒子和微生物,不影响A/B级洁净区的环境;
- 经过伽玛射线照射双层包装,保证产品无菌,确保消毒消毒液使用时不会对A/B级区环境及所生产药品产生二次污染;
- 生产环境的优势:注射用水配制、全封闭转移过滤超滤、局部A级环境灌装、B级环境内包装,生产全过程洁净控制,确保产品优良性质;
- 杀菌谱广:产品种类齐全,杀灭微生物的种类包括细菌、真菌、芽孢和病毒;
- 符合欧盟药品GMP规定,附录1:灭菌产品生产企业,2003;
- 符合制造业化学家协会(MCA)“药品生产及分销企业法规”,附录1:灭菌产品生产企业;
- 符合FDA工业界指南草案:无菌工艺生产的灭菌药品,美国FDA ;
- 符合中国GMP附录《无菌药品》的规定;
二、产品的各项性能经过严格的验证和试验
- 稳定性验证:产品常温和加速稳定性经验证,确保有承诺的有效期内,其性质稳定;
- 开瓶有效期验证:确保在1个月内反复使用的情况下产品无菌、无微粒、无细菌内毒素的特性及微生物杀灭效果稳定;
- 密封完整性验证:确保产品从出厂到洁净区使用的过程中,其各项性质稳定。
- 材料相溶性验证:确保对消毒对象即有稳定的微生物杀灭效果,也确保产品不对消毒物体产生腐蚀 。
- 产品检测方法验证:确保产品各项性能的检验方法准确可靠。
- 产品理化性质稳定:各个产品出厂均经严格检验,有效成份含量、PH值等均符合国家标准或企业标准规定,且其稳定性均经过验证合格;
三、使用优势
- 产品品类齐全,能够满足各种微生物杀灭的需求;
- 产品装量规格齐全,规格包括500ml/瓶、1000ml/瓶、3.78L/瓶,满足各种使用量的需求;
- 产品浓度规格齐全:从低浓度直接使用到高浓度稀释使用均可选择,可选择喷嘴类规格直接拆包使用,也可以选用开盖分装使用方式;
Instructions for Compound Peroxide Disinfectant
Proprietary Name:Compound Peroxide Disinfectant
Specification: Liquid, packing 500ml/bottle、1L/bottle and 3.78L/bottle
Active Ingredient and Content: Hydrogen peroxide, 1.3%~1.7%; Peracetic acid, 0.085%-0.115%
Pharmacological Actions: Can kill intestinal pathogenic bacteria, suppurative coccus, pathogenic yeast and common bacteria of hospital infection.
Application: Suitable for object surface disinfection
Usage: Apply directly, spray, wipe or soak
1. Surface disinfection: Spray the original liquid evenly on the surface of the object, keep it moist or wipe the surface of the object, effect ≥5min.
2. Immersion disinfection: completely immerse the article in the original liquid of the product, the effect is ≥5min.
Attention: 1.This product is corrosive to some extent, irritating to eyes, mucous membrane or skin, and may cause burns. In case of contact, flush with plenty of water and seek medical advice immediately.
- Wear personal protective equipment when performing disinfection operations.
- In case of container rupture or leakage, should wash with a lot of water, or absorb the residual liquid with sand and inert absorbent, meanwhile take appropriate safety protection measures.
- The disinfectant is inflammable and explosive, and will cause combustion and explosion in case of open fire and high heat. There is a risk of combustion and explosion in contact with reducing agent or metal powder.
Storage: Keep well ventilated, away from light and sealed in a cool place
LOT No.:Label attached
MFD: Label attached
EXP: 12Months
Manufacturer:Hunan Xiangyikang Pharmaceutical Co. LTD
Manufacture Address: Jinshan Community, Heba Town, Datong Lake District, Yiyang City, Hunan Province
Marketing Enterprise: ANHUI CARAEE PHARMACEUTICAL TECHNOLOGY CO., LTD.
Accountability Unit:ANHUI CARAEE PHARMACEUTICAL TECHNOLOGY CO., LTD.
No. of Manufacture Hygienic License: Hunan (2020)No. 0069
Standard: Q/AHJR010-2022
Service Telephone: 400-1021-500
Website:http://www.ahcaraee.com