Pharmaceutical Equipment Services

Gansons delivers pharmaceutical equipment services that go beyond the initial purchase – supporting your team from first process trial through to long-term aftermarket care. As a cGMP pharmaceutical equipment manufacturer operating since 1947, we understand that the value of our equipment depends entirely on how reliably it performs throughout its working life.

Our services team includes pharmacists, process technologists, validation engineers, and service engineers with direct expertise across all Gansons equipment – from The GansCoater® and SuperGran® granulation suites to fluid bed systems, powder handling, and automation platforms. We are your equipment lifecycle partner for every installation, from concept trial to commercial production and beyond.

Process Development Trials, Equipment Selection & Optimisation

  • What is the right equipment for my process?
  • How do we scale up our proof-of-concept to commercial production?
  • How can we reduce batch-to-batch variation and improve yield?
  • How do we run a Design of Experiments (DoE) on our granulation or coating process?

All great questions.

These are the questions our customers bring to us every day. With 77 years of process engineering experience across pharmaceutical, food, chemical and personal care manufacturing — and an on-site Innovation Centre equipped with laboratory-scale and pilot-scale models of our full equipment range — Gansons is uniquely positioned to answer them.

Our Mumbai Innovation Centre provides a confidential, GMP-controlled environment for pharmaceutical process development trials and equipment evaluation. Services include:

  • Process development trials — granulation, drying, coating, blending, milling and powder transfer
  • Proof-of-concept studies for new formulations or novel process requirements
  • Scale-up from lab to pilot to commercial production on the same equipment platform — eliminating technology transfer risk
  • Technology Transfer (TT) support for site changes or new product introductions
  • Design of Experiments (DoE) for process characterisation and optimisation
  • Process parameter optimisation to improve output, reduce batch variation, or increase yield
  • Equipment selection trials to determine the correct specification before capital commitment

Trials are conducted under confidentiality agreement and are supported by a full process report. Our process technologists work alongside your formulation and production teams to ensure trial outcomes are directly applicable to your production environment.

Equipment Training & Qualification Support

Finding skilled talent can be challenging. In cGMP pharmaceutical manufacturing, the gap between a qualified piece of equipment and a compliant production operation is your team’s knowledge. Gansons equipment training programmes are designed to close that gap – ensuring your operators, engineers and quality teams can use, maintain, troubleshoot and qualify Gansons equipment to the regulatory standards your facility requires.

Training is available on-site at our Thane headquarters, at your facility, and online – tailored to your specific equipment configuration and production context. Our programmes invest in your most valuable asset: your people.

  • Machine operation and best practices for cGMP pharmaceutical production
  • Preventive maintenance — schedules, procedures and documentation
  • Engineering and maintenance staff training for mechanical and automation systems
  • Root cause analysis and systematic troubleshooting for production deviations
  • Equipment parameter optimisation and process performance improvement
  • Design of Experiments (DoE) — experimental design for process characterisation
  • Equipment qualification support — understanding IQ, OQ and PQ protocols and your team’s role in the qualification process
  • Risk mitigation training — GMP risk assessment, change control and deviation management
  • Automation and Pharma 4.0 — operating and maintaining SCADA-integrated and Industry 4.0-enabled equipment
  • 21 CFR Part 11 and electronic batch record management for automated Gansons equipment

Equipment Training & Qualification Support

Finding skilled talent can be challenging. In cGMP pharmaceutical manufacturing, the gap between a qualified piece of equipment and a compliant production operation is your team’s knowledge. Gansons equipment training programmes are designed to close that gap – ensuring your operators, engineers and quality teams can use, maintain, troubleshoot and qualify Gansons equipment to the regulatory standards your facility requires.

Training is available on-site at our Thane headquarters, at your facility, and online – tailored to your specific equipment configuration and production context. Our programmes invest in your most valuable asset: your people.

  • Machine operation and best practices for cGMP pharmaceutical production
  • Preventive maintenance — schedules, procedures and documentation
  • Engineering and maintenance staff training for mechanical and automation systems
  • Root cause analysis and systematic troubleshooting for production deviations
  • Equipment parameter optimisation and process performance improvement
  • Design of Experiments (DoE) — experimental design for process characterisation
  • Equipment qualification support — understanding IQ, OQ and PQ protocols and your team’s role in the qualification process
  • Risk mitigation training — GMP risk assessment, change control and deviation management
  • Automation and Pharma 4.0 — operating and maintaining SCADA-integrated and Industry 4.0-enabled equipment
  • 21 CFR Part 11 and electronic batch record management for automated Gansons equipment

Commissioning and Documentation

IQ, OQ, FAT and Qualification Documentation Support

When you commission Gansons equipment, you are not simply installing a machine. You are building the documented evidence trail that proves to your quality team,  and to the US-FDA, UK-MHRA or European Medicines Agency – that the equipment is fit for its intended purpose. Gansons’ commissioning and qualification service is designed to make that process as efficient and audit-ready as possible.

The Gansons Qualification Lifecycle

Qualification is most effective – and least costly, when it is planned from the beginning of a project, not treated as a documentation exercise at the end. Gansons supports your qualification programme at every stage of the equipment lifecycle from design through to operational readiness.

Factory Acceptance Testing (FAT) is conducted at Gansons Thane manufacturing facility before despatch and provides documented evidence that the equipment meets the agreed specifications at source. Your team is invited to attend FAT in person, or to participate via live-stream for remote witnessed testing.
Gansons FAT documentation includes: equipment functionality tests against acceptance criteria; materials of construction certificates; weld documentation and traceability; surface finish measurement records (Ra values); calibration certificates for all critical instruments; and software version records for automated systems. Our FAT package is structured to minimise re-testing during subsequent IQ and OQ – saving your qualification team time and cost.

Installation Qualification (IQ) documents that the equipment has been correctly delivered, installed, and configured in accordance with the approved design specifications and manufacturer requirements. Gansons IQ documentation covers: equipment receipt verification against purchase order and DQ; installation location and cleanroom classification compliance; utility connection verification (electrical, compressed air, water, steam); materials of construction and surface finish confirmation; calibration certificates for all instruments; software version and configuration baseline record; and spare parts inventory verification.
Gansons can supply IQ documentation only for execution by your validation team, or provide an engineer on-site to support protocol execution – whichever suits your project requirements.

Operational Qualification (OQ) verifies that the equipment operates within its defined parameters across the full operating range, including alarm challenges, interlock testing and worst-case scenarios. OQ test protocols are developed in accordance with the Functional Specification, the Functional Risk Assessment (FRA) and the risk-based test scope determined during DQ. Gansons OQ documentation includes a Traceability Matrix linking each requirement to its corresponding OQ test – a structure required for EU GMP Annex 15 compliance and recommended by GAMP 5.

Following commissioning, Gansons process engineers remain on-site to support your operators through the initial production phase. We typically assist your team through three demonstration batches to stabilise the process, optimise equipment parameters, and build operator confidence – helping to establish a robust and repeatable manufacturing process before your team takes full operational ownership.

This hands-on support bridges the gap between equipment commissioning and your own internal qualification activities. Our process technologists work alongside your production, quality and engineering teams to document process parameters, identify and resolve early-stage operational issues, and provide the practical knowledge transfer that turns a newly installed piece of equipment into a reliable production asset.

All Gansons PLC, SCADA and HMI-based automation systems are developed and validated in accordance with GAMP 5 (Good Automated Manufacturing Practice, 5th Edition). Gansons GAMP 5 deliverables include:

  • Software Category classification (Cat 3 Configurable, Cat 4 Configured Products, Cat 5 Custom Software) for all automation components
  • Functional Risk Assessment (FRA) — risk-based determination of validation scope using FMEA methodology
  • Software Design Specification (SDS) and Software Test Specification (STS)
  • V-model testing lifecycle — documented traceability from Functional Specification through to Release Approval
  • 21 CFR Part 11 compliance: audit trail, user access controls, data integrity protection, and electronic batch record capability
  • Change control procedures for post-release software modifications, maintaining the validated state throughout the equipment lifecycle

 

For equipment installed in potentially explosive atmospheres, Gansons provides specialist commissioning aligned with ATEX Directive 2014/34/EU (EU) and the IECEx scheme (international), in accordance with IEC 60079-14 (Installation) and IEC 60079-17 (Inspection and Maintenance). ATEX/IECEx commissioning documentation includes: equipment Ex certificate verification against the site’s area classification drawing; initial inspection report to IEC 60079-17; earthing, bonding and connection verification; and functional safety testing of explosion-protected components.

Pharmaceutical GMP guidelines require periodic requalification of critical equipment and requalification following any significant change. Gansons provides change control support and requalification documentation to maintain your equipment’s qualified status throughout its operational life – covering software updates, component replacements, equipment relocations, and process changes.

Spare Parts & Aftermarket Support - Keeping Your Equipment Qualified and Running

Unplanned equipment downtime in cGMP pharmaceutical manufacturing carries a dual cost: lost production and potential GMP non-compliance. Gansons’ global aftermarket support network is structured to minimise both.

Our 24-hour remote support team responds 365 days a year. Our on-site service engineers can be mobilised to your facility within 72 hours from anywhere in our global service network — covering India, the UK and Europe, Southeast Asia, the Middle East, and beyond.

Gansons uses only original equipment manufacturer (OEM) components sourced from globally accredited suppliers with contractual commitments to long-term parts availability. All replacement parts are supplied with full traceability documentation — supporting your equipment change control records and GMP qualification status.

Our components are selected for compatibility with cGMP manufacturing environments: materials of construction, surface finishes, and component specifications are consistent with the original equipment qualification documentation, protecting the validated status of your equipment.

We believe in a ‘fix it first, ask questions later’ policy when it comes to addressing issues with our equipment. Our priority is to get your operations back up and running as quickly as possible.

All Gansons equipment is supplied with a recommended critical spare parts kit — covering the components most likely to require replacement during normal service life. Standard consumable parts are held in stock at our Thane warehouse for immediate despatch. Custom and specialist components are manufactured to order with the fastest lead times in the industry.

For customers requiring greater production continuity assurance, Gansons offers Preventive Maintenance Agreements — scheduled service visits from Gansons engineers, equipment performance verification, and recommended parts replacement at defined intervals, keeping your equipment in a state of continuous qualification readiness.

  • OEM spare parts supply with full traceability documentation
  • Preventive maintenance scheduling and on-site execution
  • Equipment performance verification and re-qualification support
  • Automation software updates and 21 CFR Part 11 compliance maintenance
  • Upgrade and retrofit programmes for existing Gansons installations
  • Equipment relocation and re-commissioning support

Spare Parts & Aftermarket Support - Keeping Your Equipment Qualified and Running

Unplanned equipment downtime in cGMP pharmaceutical manufacturing carries a dual cost: lost production and potential GMP non-compliance. Gansons’ global aftermarket support network is structured to minimise both.

Our 24-hour remote support team responds 365 days a year. Our on-site service engineers can be mobilised to your facility within 72 hours from anywhere in our global service network — covering India, the UK and Europe, Southeast Asia, the Middle East, and beyond.

Gansons uses only original equipment manufacturer (OEM) components sourced from globally accredited suppliers with contractual commitments to long-term parts availability. All replacement parts are supplied with full traceability documentation — supporting your equipment change control records and GMP qualification status.

Our components are selected for compatibility with cGMP manufacturing environments: materials of construction, surface finishes, and component specifications are consistent with the original equipment qualification documentation, protecting the validated status of your equipment.

We believe in a ‘fix it first, ask questions later’ policy when it comes to addressing issues with our equipment. Our priority is to get your operations back up and running as quickly as possible.

All Gansons equipment is supplied with a recommended critical spare parts kit — covering the components most likely to require replacement during normal service life. Standard consumable parts are held in stock at our Thane warehouse for immediate despatch. Custom and specialist components are manufactured to order with the fastest lead times in the industry.

For customers requiring greater production continuity assurance, Gansons offers Preventive Maintenance Agreements — scheduled service visits from Gansons engineers, equipment performance verification, and recommended parts replacement at defined intervals, keeping your equipment in a state of continuous qualification readiness.

  • OEM spare parts supply with full traceability documentation
  • Preventive maintenance scheduling and on-site execution
  • Equipment performance verification and re-qualification support
  • Automation software updates and 21 CFR Part 11 compliance maintenance
  • Upgrade and retrofit programmes for existing Gansons installations
  • Equipment relocation and re-commissioning support

Innovation Centre - Regulatory Grade Process Development

Our state-of-the-art Innovation Centre is equipped with laboratory and pilot-scale models of the full Gansons equipment range, operated in a controlled, regulatory-grade environment. The facility is designed for proof-of-concept trials, process optimisation studies, and scale-up work  generating documented process data directly usable in technology transfer reports and regulatory submissions.

The Innovation Centre operates as a carbon-neutral R&D facility. Process development data generated here is structured to support your design space documentation under QbD principles, and our process technologists can assist in the preparation of process characterisation reports suitable for regulatory filing.

Work conducted at the Innovation Centre answers the questions that hold up regulatory submissions:

  • Can this hygroscopic product be aqueous coated without stability impact?
  • Can this powder mix be vacuum transferred without segregation?
  • Can this HPAPI process be contained to OEB 5 at pilot scale?

    These are not rhetorical questions at Gansons – they are projects we have delivered.

Every Gansons Installation is Backed by a Lifetime of Support

From your first process development trial at our Innovation Centre through to commissioning, equipment qualification, operator training and long term aftermarket support – our services team is with you at every stage of your equipment’s working life. Speak to our team today about how Gansons can support your facility.