Ahmedabad and the wider Gujarat corridor, including Vadodara, are home to many pharma machinery makers. They build tablet presses, granulation and coating equipment, capsule fillers, liquid filling lines, process vessels and packing machines. Gujarat has a large pharmaceutical industry, and its machinery makers grew up supplying it.
Many of these makers export, and some supply plants that are inspected by strict regulators. Others build mainly for the domestic market. The machine type alone tells you little about which kind of maker you are dealing with.
What is made, by process
- Granulation equipment, such as rapid mixer granulators, fluid bed dryers, multimills and blenders.
- Compression equipment, mainly rotary tablet presses in single-sided and double-sided versions.
- Coating machines for film and sugar coating of tablets.
- Capsule filling machines, from semi-automatic to fully automatic.
- Liquid and ointment equipment, such as manufacturing vessels, homogenisers, filling machines and cappers.
- Sterile processing equipment, such as vial washers, depyrogenation tunnels and vial fillers, which is a more specialised field.
- Packaging lines, such as blister packers, cartoners, labellers and serialisation systems.
What separates one maker from another
Pharma machines are judged as much by their design and paperwork as by their output. Look at these points when you compare makers:
- Hygienic design of product contact parts, explained in GMP design for machines.
- Contact parts in stainless steel 316L with material certificates and measured surface finish.
- A full qualification pack, covered in DQ, IQ, OQ and PQ documents.
- Control software with user access levels, audit trails and data storage that meet your regulator's expectations for electronic records.
- Reference installations at plants that have passed inspections in your target market.
- A service network or remote support arrangement for your country.
Who is responsible for compliance
Medicines regulators approve and inspect the medicine manufacturer, not the machine. The machine maker supplies equipment and documents. Your company is responsible for qualifying the machine and validating the process under the GMP rules that apply to you, such as EU GMP or US cGMP.
If the machine goes to the EU, it also needs CE marking under machinery law. That is a separate question from GMP, covered in CE marking for machinery. Confirm the requirements with your quality team and, where needed, a notified body or regulatory adviser.
Before you order
Write a user requirement specification first. It sets out output, product range, materials, controls and documents in numbers. Makers then quote against the same document, which makes quotes comparable.
Visit the works, see the machine type being built and check how welds and surfaces are finished. Then agree a factory acceptance test with clear pass criteria before you release the balance payment.
Ask early about lead time, because pharma machines are often built to order with custom documents. A delay in the qualification pack can hold up your plant as much as a delay in the machine itself.
Next step
We find and audit pharma machinery makers, check their documents and supervise factory tests before shipment. To discuss your project, book a free sourcing review.