Product Description
Specification
Product Name | GMP Empty Gelatin Capsule |
Size Available | 000# 00#, 0#OEL, 0#, 1#, 2#, 3#, 4#，5# |
Color | Could be customized according to samples |
Material | Pharmaceutical grade gelatin |
Printing | Printed words or logo on capsules are available |
Storage Condition | Temperature 15º C to 25ºC Humidity: 35% to 65% |
Shelf Life | 5 years (60 months) |
Production Process:
Colors:
Specification:
Technical Specification of GMP Empty Gelatin Capsule
Certificate of Analysis:
Test item | Unit | Standards | Test result |
Tightness | ____ | There shall be no adhesion, deformation or rupture: | In line with the provisions |
Brittle broken degree | ____ | Not more than 5 pcs rupture | In line with the provisions |
Disintegration time | min | ≤10 min | 7 |
Viscosity | mm2 /s | ≥60mm2 /s | 65 |
Sulfite | % | Should not be more than 0.01% | In line with the provisions |
Chloroethanol | ___ | Chloroethanol test solution peak area no larger than the peak area of | In line with the provisions |
Ethylene Oxide | % | Shall not be greater than the control solution peak area (0.0001%) | In line with the provisions |
Dry weight loss | % | 12.5%-17.5% | 14.57 |
Residue on ignition | % | Residue couldn't more than 2.0% (transparent), 3.0% (translucent) | 2.86 |
Chrome | ppm | Couldn’t more than 2 millionths | <2 |
Heavy metal | ppm | Couldn’t more than 40 millionths | <40 |
Total plate count | Cfu/g | ≤1000 | Qualified |
Yeast and mold | Cfu/g | ≤100 | Qualified |
Escherichia coli | ___ | Not detected | Qualified |
Salmonella | ___ | Not detected |
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:
Packing List | |||
Size | Packing | N.W. | G.W. |
000# | 50,000pcs/CTN | 10.00kg.CTN | 12.00kg/CTN |
00# | 80,000pcs/CTN | 10.00kg/CTN | 12.00kg/CTN |
0# | 100,000pcs/CTN | 11.50kg/CTN | 13.50kg/CTN |
1# | 140,000pcs/CTN | 12.50kg/CTN | 14.50kg/CTN |
2# | 180,000pcs/CTN | 12.50kg/CTN | 13.50kg/CTN |
3# | 240,000pcs/CTN | 12.50kg/CTN | 14.50kg/CTN |
4# | 300,000pcs/CTN | 12.50kg/CTN | 14.50kg/CTN |
5# | 400,000pcs/CTN | 12.50kg/CNT | 14.50kg/CTN |
Certificates:
The company has passed ISO9001, ISO14001 and ISO22000 certification, and has gained FDA certification, HALAL, KOSHER, BRC and DMF certification.
