Product Description
Product Name | OX Bone Vacant Capsule |
Raw Material | 100% of Bone Glue |
Size Avaliable | 00#, 0#, 1#, 2#, 3#, 4#，5# |
Color | Could be customized according to samples or requirements |
Printing | Ring Printing, Axial Printing, Specified Radial Printing, Circumferential Printing |
Certificate | ISO9001,ISO1400,ISO22000,FDA,HALAL, KOSHER, BRC and DMF |
Name | Gelatin Capsule |
Material | 100% Bone Glue |
Heavy Metal Content | <40-50ppm |
Preservative | Free |
Storage Temperature | 10-25℃ |
Low Temperature | Brittle Broken |
High Temperature | Flexible Softening |
Storage Humidity | 35-65% |
Filling Rate | 99.9% |
Suitable Crowd | Except vegetarian Judaism Islam |
Shelf Life | 24 months |
Production Process:
Colors:
Specification:
Technical Specification of OX Bone Vacant Capsule | ||||||
Size | Specification Size | |||||
Length,cap | Length,body | Single wall thickness,cap | Single wall thickness,body | Average weight | Limited weight | |
00# | 11.9+/-0.4 | 20.4+/-0.4 | 0.115+/-0.015 | 0.110+/-0.015 | 125+/-6 | Averageweight+/-12 |
0# | 11.0+/-0.4 | 18.5+/-0.4 | 0.110+/-0.015 | 0.105+/-0.015 | 98+/-5 | Averageweight+/-9 |
1# | 9.9+/-0.4 | 16.5+/-0.4 | 0.105+/-0.015 | 0.100+/-0.015 | 75+/-4 | Averageweight+/-7 |
2# | 8.9+/-0.4 | 15.3+/-0.4 | 0.100+/-0.015 | 0.095+/-0.015 | 60+/-4 | Averageweight+/-6 |
3# | 8.1+/-0.4 | 13.6+/-0.4 | 0.095+/-0.015 | 0.095+/-0.015 | 52+/-4 | Averageweight+/-5 |
4# | 7.1+/-0.4 | 12.1+/-0.4 | 0.095+/-0.015 | 0.095+/-0.015 | 40+/-4 | Averageweight+/-4 |
Physical and Chemical Items | |
Test Item | Standard |
Characteristics | This product is cylinder, by can set close and lock cap and body composed of two qualitative hard and elastic empty capsules. Capsule should be bright and clean, color and luster is uniform, smooth incision, no distortion, no odor. This article is divided into transparent (two does not contain sunscreen), translucent (section contains a sunscreen only), opaque (two contain sunscreen). |
Identification | Shall be positive |
Tightness | ≤1 |
Brittleness degree | ≤5 |
Disintegration time limit | ≤10.0mins |
Sulfite | ≤0.01% |
Chloroethanol | Shall be positive |
ethylene oxide | ≤0.0001% |
Drying weightlessness | should be 12.5-17.5% |
Burning residue | ≤2.0%(transparent),3.0%(semi-transparent),5.0%(opaque) |
Chromium(ppm) | ≤2 |
Heavy metal(ppm) | ≤20 |
Aerobic bacteria count | ≤1000cfu/g |
Molds and yeast | ≤100cfu/g |
Escherichia coli | Negative |
Salmonella | Negative |
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%.
100% Bone Glue Capsules | Capsules With Added Skin Glue | |
Chromium Content | 0.4ppm | 2ppm |
Brittleness | very stable | more likely to break Especially at low temperature, the usage rate of capsules with added skin glue is greatly reduced |
Deformation | less easily deformed than capsules with added skin glue | more easily deformed in the high temperature |
Test Pass Rate | reach 99% on average | lower than 100% bone glue capsules |
2. GMP Workshop
3. Advanced Equipment:
4. Quality control
QC in workshop and packaging. Besides automatic machine checking, workers also check size,sewing and work desk to make sure the products meet quality. Physical and chemical indexes of finished capsule would be checked before packaging. Only the qualified capsule would be packed for clients.
5. Quality complains
In case customers make quality complains, we’ll forward it to our service team. They will report directly to our factory manager. Usually we will hold a meeting with production, purchasing and packaging departments in 24 hours, and will response in 48 hours with feedbacks and solution.
Packing:
Packing:polybag+Aluminum foil+foam board+carton box(size:60*41*74.5cm) | |||||||||
Size | Qty | N.W | G.W | Weight | Volume | Capacity | |||
0.6g/(ml) | 0.8g/(ml) | 1.0g/(ml) | 1.2g/(ml) | ||||||
00# | 70,000 | 8.5 | 11.5 | 122+/-10 | 0.79 | 444mg | 592mg | 740mg | 888mg |
0# | 100,000 | 10 | 13 | 97+/-8 | 0.67 | 408mg | 544mg | 680mg | 816mg |
1# | 140,000 | 11 | 14 | 77+/-6 | 0.5 | 300mg | 400mg | 500mg | 600mg |
2# | 180,000 | 11 | 14 | 62+/-5 | 0.37 | 222mg | 296mg | 370mg | 444mg |
3# | 240,000 | 12 | 15 | 49+/-4 | 0.3 | 180mg | 240mg | 300mg | 360mg |
4# | 300,000 | 12 | 15 | 39+/-3 | 0.21 | 126mg | 168mg | 210mg | 252mg |
Certificates:
