Following services can be provided to Customers from our side.
- Customer can utilize our lab for small trials during development phase to carry out initial feasibility / compatibility studies.
- We can take up any trials for customer with material input from customer on feasibility and compatibility.
- We can develop product for customer.
- We have experienced Pharma R & D personnel.
- We can provide guidance on powder formulation.
- We can provide guidance on liquid fill formulation.
- We can guide and assist the customer on banding technology.
- We can carry out Photostability studies for customer.
- Any other study on capsules where customer would like us to carry out.
Certificate of Analysis
ACG ACPL gives COA with each lot of capsules supplied. It gives test results of analysis of the representative sample from each batch. The COA also serves as a ready reference for colorants / ingredients used in the batch along with their Pharmacopoeial reference.
The capsules are manufactured in a GMP facility under the survellance of Croatian Health Ministry. The raw materials used in the manufacture of capsules comply to applicable regulations in the country of use.
Gelatin complies with the current Ph. Euro, USP and equivalent international Pharmacopoeia. Bovine gelatin used in the manufacture of capsule shells conforms to the Ph. Eur Monograph (current edition) "Products with risk of transmitting agents of animal spongiform encephalopathies" It is procured from suppliers who have certified by the EDQM. Porcine gelatin meets necessary national regulations.
Colorants used in the capsule shells conform to EC Directives. It is ensured that they are permitted for use in drugs in the country where intended to be used. Colorants conforming to CFR standards are used where applicable Titanium Dioxide conforms to Ph. Euro, USP & Iron Oxides conforms to US/NF & EC Directives.
Quality Management System
Our capsules are manufactured on highly automated state of the art machinary in a controlled environment. The facility operates a QMS in line with ISO 9001:2008 and has been certified by Bureau Veritas.
Safety, Health & Environment is of prime concern to ACG ACPL. The facility is certified for compliance to ISO 14000 standards.
Quality is built into ACG ACPL capsules through design of system, manufacturing equipments well defined sampling plans & stringent process checks. This ensures optimum performance on the high speed filling machines.
ACG ACPL has a team of technically competent service personnel who specialize in the area of interface of capsules with the filling machines. This team works to understand customer filling machine / filling condition requirements & translate them back to design to ensure a snug fit between our product & customer filling machines. They also provide technical training to filling machine operators to enhance productivity using our capsules.
Technical Services Cell of ACG Associated Capsules has a team of competent staff having hands on experience on Highly sophisticated Automatic Capsule filling and allied machines besides their rich experience in Capsule manufacturing. They travel globally to provide following services.
- Conducting proactive visits for Training to users of capsules on Capsule filling machines to minimize rejects and improve the yield.
- Providing help in Self diagnosis of the problem on filling machine and subsequent packing operations.
- New product trials on filling machine for samples or commercial lots. Finding customized solutions for some tricky products.
- The customization could be for filling operations or for the empty capsules.
- Prompt actions on product complaints on filling machines for resolution.