Quality

The Quality expectations of our customers with continual improvement in our product and services.

Proprietary technologies

Proprietary technologies
  • Set up of R&D and machine manufacturing unit in 2013.
  • We are growing at 20% CAGR - AlfaCaps LLC invests 6% of top line into research.
  • Own machine manufacturing - proprietary technologies that can not be procured.
  • from the market and are most advanced using latest technology available in the world.
  • Servo drives to replace cams.
  • PLC operated machines.
  • Process controls like SCADA to monitor critical process parameters.
  • Advanced electronic gauges to check capsule dimensions.
Proprietary technologies

Trust & Safety

Quality & Safety is our priority and a fundamental element of our business.

trust and safety
trust and safety

Quality Assurance

  • AlfaCaps LLC has a 3 decade record of safety of the product.
  • Clean room GMP facilities with High Precision Machineries.
  • AlfaCaps LLC has invested in camera inspection machines – 100% of capsules are subject to camera inspection.
  • AlfaCaps LLC recognises that product integrity and customer satisfaction are of primary importance to its success.
  • Highest quality of ingredients.
  • State of Art Laboratories for testing raw materials and product through the process.
  • Certification and compliance by govt agencies enabling AlfaCaps LLC to supply its product to pharma and the H&N companies world over.
Quality Assurance

Technical Specifications

Filling Capacity
Size 00 0el 0 1 2 3 4
Volume (ml) 0.95 0.78 0.68 0.50 0.37 0.30 0.21
Capacity
(mg)
0.8g/cc 760 624 544 400 296 240 168
1.0g/cc 950 780 680 500 370 300 210
1.2g/cc 1140 936 816 600 444 360 252
HPMC Capsules
Size Length (mm) Thickness (mm) Avg.
Weight
(mg)
Cap Body Pre
Locked
Locked Cap Body
00 11.8 20.1 25.5 23.0 0.110 plus minus0.0200 0.110 plus minus0.0200 127.0
0 11.1 18.5 23.7 21.4 0.110 plus minus0.0200 0.110 plus minus0.0200 102.0
1 10.0 16.6 21.4 19.3 0.110 plus minus0.0200 0.105 plus minus0.0200 78.0
Tolerance plus minus0.4 plus minus0.4 plus minus0.4 plus minus0.4 - - plus minus10%
Gelatin Capsules
Size Length (mm) Thickness (mm) Avg.
Weight
(mg)
Cap Body Pre
Locked
Locked Cap Body
00 11.8 20.1 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 11.1 18.5 23.7 21.4 0.109 0.102 96.0
1 10.0 16.6 21.4 19.3 0.105 0.100 76.0
2 9.2 15.2 19.6 17.8 0.104 0.098 63.0
3 8.2 13.5 17.7 15.8 0.099 0.094 49.0
4 7.5 12.2 16.4 14.5 0.097 0.091 40.0
Tolerance plus minus0.4 plus minus0.4 plus minus0.4 plus minus0.4 plus minus0.018 plus minus0.018 plus minus0.7%

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.

Vision Inspection

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.

Certification

  • DMF registered with USFDA
  • WHO GMP Certified
  • Hlal Certified
  • Kosher Certified
  • ISO 9001:2008