Product Description
Specification
Product name | GMP Hollow Gelatin Capsule |
Size | 000#,00#,0#OE, 0#, 1# 2# 3# 4# ,5# |
Color | Customized according to the customers’ requirement |
Material | High quality pharmaceutical gelatin approved by Chinese official, BSE free |
Certificates | ISO9001, HALAL, Kosher, GMP, DMF, FDA,BRC etc. |
Printing | Customized according to the customers’ requirement |
Store condition | Clean room, temperature 10-25℃,related humidity 35-65%;Suggest you set it to be: Temperature 20℃,related humidity 50% |
Technical parameter | please see the follows |
Production Process:
Colors:
Specification:
Technical Specification of GMP Hollow Gelatin Capsule
Certificate of Analysis:
Elastic Tightness | Less Than 2 pcs |
Friability | Less Than 15 pcs |
Disintegration Time | ≤10 Munites |
Loss on Drying | 12.5-17.5% |
Residue on Ignition(%) | Transparent≤2 |
Semi-transparent≤3 | |
Opaque≤5 | |
Heavy Metals(PPM Pb) | ≤50 |
Viscosity(mm2/s) | ≥60 |
Micro-Organism | Total count of Bacilus: ≤ 1000unit/g |
Total count of Mildew: ≤ 100 unit/g | |
Total count of Escherichia:should not be detected | |
So2: | 0.02% max |
C2h5ocl | no |
Ash | 2.0%(for transparent capsules) |
Arsenic | 1 ppm max |
Microbiological assay | |
Mite | no |
Quality Control:
1. Raw material control
We only use 100% cattle bone glue as raw material to make medical empty capsules, filling rate reaches 99%.
2. GMP Workshop
3. Advanced Equipment:
4. Quality control
QC is in workshop and packaging. Besides automatic machine checking, workers check size, sewing and work desk to make sure the products meet quality as well. Physical and chemical indexes of finished capsule would be checked before packaging. Only the qualified capsule would be packed for clients.
Packing:
Size | Packaging(kpcs/CTN) | Carton Size(cm) | Inner packing | Outer packing |
00# | 70kpcs | 60*40*74 | 1pc opp bag,1pc aluminum foil bag, 1pc corrugated carton | Corrugated Carton |
0# | 100kpcs | 60*40*74 | ||
1# | 140kpcs | 60*40*74 | ||
2# | 180kpcs | 60*40*74 | ||
3# | 250kpcs | 60*40*74 | ||
4# | 320kpcs | 60*40*74 |
Certificates:
