Pharmaceutical Packaging Expertise
Modular Pharma Competency in Packaging Automation
Trusted packaging line automation partner to leading pharmaceutical and life sciences companies worldwide. Designed for compliance, built for performance.
Structured Delivery for Regulated Environments
Our projects are managed using Agile Project Management (SCRUM), ensuring controlled, transparent, and efficient delivery from concept to production.
From Project Kick-Off → Design Qualification → Fabrication → FAT → Installation → SAT, all projects operate in structured sprint cycles with clearly defined milestones – enabling faster delivery without compromising compliance, validation, or quality.
What Our Clients Say
Explore Our Pharma Compliance & Validation Capabilities
Built to support GMP, validation, and regulatory compliance across the full packaging lifecycle
Our projects are managed using the Agile Project Management SCRUM Method. From Project Kick-Off to Design Qualification, Fabrication, FAT, Installation and SAT Handover our projects operate in 2-4 week sprints. Clear objectives and milestones allow our agile project teams to respond quickly and efficiently which reduces lead times allowing our machines to go into full production more quickly.
Design for GMP
Machines designed with GMP principles to ensure hygienic design, easy cleaning, and full product integrity throughout the packaging process.
- Hygienic machine design
- Cleanability and accessibility
- Line clearance and contamination control
- Product quality and integrity assurance
GMP Design Features
1. Hygienic by Design
Maximum smooth surfaces and minimal holes and crevasses is achieved by careful Mechanical Design of machine frames, structural support, fixings, brackets, pneumatic piping, electrical cable routing etc.
2. Easy to Clean
We take great care to ensure the machines are designed for ease of access and cleaning. Materials are selected, which can be cleaned using standard cleaning agents such as 70% Ethanol and using the standard wipe down technique.
3. Line Clearance
There are no hidden zones for product to dwell or be unseen. Operator Interfaces have a Line Clearance Mode which reduces the time for operators to clear the line of product.
4. Product Quality and Integrity Maintained
There is positive control of the product throughout the process so that there is no impact on product quality and integrity. Components are selected which have minimal impact on the product, such as pneumatic devices with cushioning and pressure limiting, bearings which are sealed and with lifelong lubrication, materials selected which do not shed or mark the product.
Validation & Documentation
Comprehensive validation support aligned with GAMP 5 methodology, covering the full lifecycle from URS to FAT, SAT, and documentation delivery.
- URS analysis and technical specification support
- FAT, SAT, IQ, OQ, PQ validation processes
- Full validation documentation packages
- Risk-based validation and QMS alignment
- SOPs, protocols, and compliance documentation
1. Project Kick off
Kick-off is a vital phase in the project. Tekpak has an Internal Technical Project Kick-Off meeting to develop the Design Plan, identify the risks and milestones on the project. There will also be a Project Kick-Off meeting with the client project team to introduce all of the project stakeholders, agree on the schedule and clarify any open items in the URS.
2. Design Qualification
The detailed design phase of the project is where a thorough analysis of the User Requirements takes place. The Design is Risk Assessed (FMEA and Safety Risk Assessment) and the Design Specification documents are developed (FDS/HDS/SDS) as working drafts and ready for sign off at DQ with the client.
3. System Build
The longest phase in the project starts with the ordering of long lead time items and ends at Pre-FAT. This phase of the project incorporates procurement, fabrication, assembly, programming and debugging. During which time there is regular communication and status updates with the client and Design Specifications are finalised.
4. System Test & Approval
We have the capability, facilities and experience to run complete line FAT at Tekpak. In many instances, we incorporate OEM equipment to form a full line test and integration at Tekpak before installation at the client site. FAT includes IQ/OQ, Performance and Quality Tests.
5. System Handover & Training
After a successful SAT, the client personnel are trained to run the equipment through the Validation process. SAT includes IQ/OQ, Performance and Quality Tests. Any tests that could not be performed at Tekpak are also completed during this time (for example, those which rely on continuous production or other client-specific conditions).
6. Validation Support
In most cases, the client will complete their own IQ/OQ/PQ after SAT with remote support from Tekpak.
7. Go Live!
Tekpak will be available for Go Live Support should this be required.
21 CFR Part 11 Compliance
Control systems and software designed to meet 21 CFR Part 11 requirements, ensuring secure, traceable, and compliant data handling.
- Audit trails and data integrity
- User access control and permissions
- Time synchronisation and system security
- Integration with SCADA, MES, and ERP systems
Communication Protocols
Our machines can be provided with Industry 4.0 ready options and can communicate with other devices and higher-level SCADA, MES and OEE systems using defined protocols such as OPC UA, LDAP, Ethernet/IP, Profinet, I-O Link, Modbus, TCP/IP etc.
Supporting Global Regulatory Requirements
We support pharmaceutical and life sciences companies in meeting global regulatory requirements across manufacturing and packaging systems.
- EU GMP Annex 11
- FDA 21 CFR Part 11
- GAMP 5 methodology
- Data integrity & audit trails
- MES / SCADA system integration
- Computer system validation (CSV)
Supporting Regulated Industries
Pharmaceuticals
End-to-end packaging automation with full compliance support
Biotech
Validated systems for complex and sensitive production environments
Medical Devices
Precision packaging systems aligned with MDR and FDA requirements
Cosmetics
Flexible labelling systems for varied product formats
Designed for Compliance. Built for Production.
Pharmaceutical manufacturing environments demand more than just automation – they require validated systems, traceable processes, and regulatory alignment at every stage.
Tekpak combines engineering expertise with compliance understanding, ensuring that every system is designed not only to perform, but to meet the strict requirements of regulated industries.
