Services

Contract Manufacturing

Ajinomoto CELLiST Korea具备基于优秀医药品生产及质量管理标准(cGMP)的生产设备和管理体系。我们根据客户的要求,从工艺特殊的氨基酸混合物到商业生产用培养基及补料产品,提供多种粉末剂型产品的生产服务。

Manufacturing Capacity

生产能力

: 不同生产规模以及多种包装规格可供选择。

Container(L) Minimum 20L ~ Maximum 2000L
Scale(kg) ~10kg ~ ~1ton

Annual maximum production capacity

: 200 ton (1 ton x 200 batches)

生产流程

1. 称量
  • 从毫克到公斤,使用通过校验的称量设备,准确称量指定的原料。
2. 粉碎及混合
  • 为了得到均匀而稳定的粒度而实施粉碎。
  • 使用微粉碎机均匀粉碎产品原料。
  • 根据生产规模进行捣碎混合,以保证混合均匀。
  • 根据原料的特点和生产规模,在整个生产过程中采用了分离的预混合工序。
3. 过筛
  • 以1毫米、2毫米规格进行过筛,以防止异物混入。
4. 最终混合
  • 最终混合已完成过筛工序的原料。
5. 包装&贴标
  • 利用自动填充设备按要求数量进行包装并贴标签。

Test Item

Product quality are evaluated by the following tests
  • Appearance (powder, after dissolving)
  • Loss on drying
  • pH (after dissolving)
  • Osmotic pressure (after dissolving)
  • Cell culture test
  • Endotoxin test
  • Microbial limit testing (TAMC: NMT 100cfu/g, TYMC: NMT 20cfu/g)
  • Mycoplasma

针对不同重量提供包装类型

Aluminum pouch 6L Plastic drum 20L Plastic drum 60L Plastic drum
Amount(kg) ~0.050kg ~3kg ~10kg ~20kg
Amount(L) ~1L ~50L ~500L ~1,000L

*可根据客户要求变更/补充包装材料

Privacy Policy

1. General

2. Purpose of processing personal information

The Company processes personal information for the following purposes. The personal information being processed will not be used for purposes other than the following purposes, and if there is a change to the purpose of use, prior consent will be asked for.

3. Personal information processing time and retention period

4. Matters concerning the provision of personal information to a third party

5. Rights and obligations of the subject of information and its legal representative, and how to exercise them

Users can exercise the following rights as the subject of personal information.

6. Personal information items subject to processing

7. Destruction of personal information