Quality Assurance
Raw material quality control
In order to guarantee safety and stability, all the raw materials for our capsule is inspected rigidly according to Enterprise quality standards which is made on the bases of State pharmacopoeia.
Quality Control in Manufacturing
Sampling inspection is conducted during the producing process to keep all the parameters in right normal scope to strengthen quality stability.
Glue dissolution: The temperature, color and viscosity are monitored under strict control.
Capsule production: appearance, dimension and moisture are checked by quality controller. Environment temperature and moisture level in factory room, as well as glue viscosity and temperature are monitored by the operator.
Screening Process: The sorted capsule by sorting machine is inspected by quality controller further to ensure all the capsule for sale meet quality standards. The sorting parameter is adjusted and controlled by workers in charge of sorting machine running.
Finished Product Management
Physical & chemical indexes of finished capsule would be checked before packaging. Only the qualified capsule would be packed for clients.
Tracking of Product
According to GMP regulation, all the capsule are packed with clear batch number and the quality records are made for tracking if necessary.
FAQ
QA: What is your minum order quantity?
- MOQ is one carton
Custom printing and special color needs 1million/design/size/color.
QA: Do you have any certifications?
-Sure, our factory has more than 33 years history, passed FDA, ISO9001, HALAL, DMF and so on.
QA: Such high quality capsules would be expensive?
-Don't worry, we are manufacturer not distributor or any agent. We will try our best to offer you a price that fits your budget
QA: What is your raw material?
- Pharmaceutical gelatin/ Pullulan/ HPMC
Items | Results |
Elastic Tightness | Less than 2pcs |
Friability | Less than 15pcs |
Disintegration Time | 10 Minutes |
Loss on Drying | 12.5-17.5% |
Residue after Ignition (%) | Transparent: ≤2 |
Heavy Metals (ppm) | ≤50 |
Viscosity (mm2/s) | ≥60 |
Micro-Organism | Total count of Bacillus: ≤1000unit/g, |
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