Quality Assurance
Alfacaps produces high quality capsules using the most advanced equipment and technology. We manufacture our own encapsulation machines ensuring precision and integrity. Over 30 years of certified safety in the production of empty capsules. Clean room GMP facilities with High Precision Machineries. We source the highest quality ingredients across our entire range. State of Art Laboratories for testing raw materials and processes. Certification supplier to pharma and the H&N companies worldwide. 100% of capsules are subject to camera inspection using advanced Visual Cap Cams.
Facility. Infrastructure.
Our facilities house some of the most advanced technical systems and machinery for capsule manufacture available today. However, it only works if our structure and set up not only meets WHO requirements and regulation, but is also designed to maximise our ability to produce the best capsule possible. Our facility was built with the guidance of experts in this field. Each Automatic Line is housed independently, we use a Uni-directional layout to eliminate cross contamination and our state of Art fully automated Gelatin room monitors all components of the process, providing critical data such as viscosity.
OUR VALUE PROPOSITION
30 years of experience Core competence in capsules Proprietary technologies & machinery Focus on R&D and backward integration 3 decades of trust, safety & product integrity Clean room manufacturing Certification & compliance Young and driven management Abundant talent & strong vendor base Customer oriented Global presence & service Technical & formulation support Optimum lead times Efficient and competitive
Technical Specifications
Filling Capacity Size 00el 00 0el 0 1 2el 2 3 4 Volume (ml) 1.02 0.95 0.78 0.68 0.50 0.41 0.37 0.30 0.21 Capacity (mg) 0.8g/cc 816 760 624 544 400 328 296 240 168 1.0g/cc 1020 950 780 680 500 410 370 300 210 1.2g/cc 1224 1140 936 816 600 492 444 360 252 Gelatin Capsules Size Length (mm) Thickness (mm) Avg. Weight (mg) Cap Body Pre Locked Locked Cap Body 00 11.8 20.2 25.5 23.0 0.110 0.105 120.0 0el 11.5 20.1 25.5 23.2 0.109 0.102 104.0 0 10.7 18.5 23.7 21.3 0.109 0.102 96.0 1 9.8 16.6 21.4 19.2 0.105 0.100 76.0 2el 9.7 16.6 21.4 19.3 0.104 0.098 66.0 2 9.0 15.2 19.6 17.6 0.104 0.098 63.0 3 8.2 13.5 17.7 15.8 0.099 0.094 49 4 7.2 12.2 16.4 14.4 0.097 0.091 40.0 Tolerance 0.4 0.4 0.4 0.4 0.018 0.018 7% HPMC Capsules Size Length (mm) Avg. Weight (mg) Cap Body Pre Locked Locked 00el 13.0 22.2 27.5 25.0 140.0 00 11.8 20.1 25.5 23.0 130.0 0 10.7 18.5 22.7 21.3 100.0 1 9.8 16.6 21.4 19.2 79.0 2 9.0 15.2 19.6 17.6 65.0 3 8.1 13.6 17.7 15.8 51.0 4 7.2 12.2 16.2 14.4 42.0 Tolerance 0.4 0.4 0.4 0.4 10% Acceptance quality level (aql) The AQL is the maximum percent nonconforming (or the maximum number of non conformities per hundred units) that, for purposes of sampling inspection, can be considered satisfactory as a process average. AlfaCaps is the first company in India to have invested in Vision Inspection machines. Passing capsules through this machine guarantees Quality. Categorization of Defects Sample Size Acceptance Number Rejection Number AQL % AOQL % CAPSULE DEFECTS Critical 1250 00 01 0.01 0.029 Major 1250 01 02 0.04 0.067 Minor 1250 07 08 0.25 0.360 The AQLs indicated above could be verified on a composite random sample drawn from vk + 1 cartons in the shipment, where k = number of cartons in the shipment.
Technical Specifications
- Filling Capacity
- Size 00el 00 0el 0 1 2el 2 3 4
- Volume (ml) 1.02 0.95 0.78 0.68 0.50 0.41 0.37 0.30 0.21
- Capacity (mg) 0.8g/cc 816 760 624 544 400 328 296 240 168
- 1.0g/cc 1020 950 780 680 500 410 370 300 210
- 1.2g/cc 1224 1140 936 816 600 492 444 360 252
- Gelatin Capsules
- Size Length (mm) Thickness (mm) Avg. Weight (mg) Cap Body Pre Locked Locked Cap Body
- 00 11.8 20.2 25.5 23.0 0.110 0.105 120.0
- 0el 11.5 20.1 25.5 23.2 0.109 0.102 104.0
- 0 10.7 18.5 23.7 21.3 0.109 0.102 96.0
- 1 9.8 16.6 21.4 19.2 0.105 0.100 76.0
- 2el 9.7 16.6 21.4 19.3 0.104 0.098 66.0
- 2 9.0 15.2 19.6 17.6 0.104 0.098 63.0
- 3 8.2 13.5 17.7 15.8 0.099 0.094 49
- 4 7.2 12.2 16.4 14.4 0.097 0.091 40.0
- Tolerance 0.4 0.4 0.4 0.4 0.018 0.018 7%
- HPMC Capsules
- Size Length (mm) Avg. Weight (mg) Cap Body Pre Locked Locked
- 00el 13.0 22.2 27.5 25.0 140.0
- 00 11.8 20.1 25.5 23.0 130.0
- 0 10.7 18.5 22.7 21.3 100.0
- 1 9.8 16.6 21.4 19.2 79.0
- 2 9.0 15.2 19.6 17.6 65.0
- 3 8.1 13.6 17.7 15.8 51.0
- 4 7.2 12.2 16.2 14.4 42.0
- Tolerance 0.4 0.4 0.4 0.4 10%
- Acceptance quality level (aql)
- The AQL is the maximum percent nonconforming (or the maximum number of non conformities per hundred units) that, for purposes of sampling inspection, can be considered satisfactory as a process average.
- AlfaCaps is the first company in India to have invested in Vision Inspection machines. Passing capsules through this machine guarantees Quality.
- Categorization of Defects Sample Size Acceptance Number Rejection Number AQL % AOQL % CAPSULE DEFECTS Critical 1250 00 01 0.01 0.029
- Major 1250 01 02 0.04 0.067
- Minor 1250 07 08 0.25 0.360
- The AQLs indicated above could be verified on a composite random sample drawn from vk + 1 cartons in the shipment, where k = number of cartons in the shipment.