Pharma Competency

Modular Design for GMP in Packaging Automation

GMP-Focused Design Built Into Every System

Tekpak designs packaging automation systems with GMP (Good Manufacturing Practice) at the core. Every machine is engineered to support hygienic operation, minimise contamination risk, and ensure consistent product quality.

Our approach ensures that systems are not only high-performing but also aligned with the strict requirements of pharmaceutical, biotech, and medical device manufacturing environments.

 
Fully customisable solutions by Tekpak

Design for GMP

Tekpak machines are designed with a GMP philosophy. This means that the machines are hygienic by design and the quality and integrity of the product, packaging and data are maintained throughout the machine processes.

We take great care during the design process to ensure the requirements of the Industries that we serve are met.

We understand that our clients operate in a Good Manufacturing Process environment and that there are certain pre-requisites for machinery in this environment.

GMP Design Features

Our machines are designed in accordance with GMP principles, focusing on cleanability, accessibility, and product protection.

1. Hygienic Design

Machines are constructed using stainless steel and designed to minimise contamination risks while supporting easy cleaning and maintenance.

2. Cleanability & Accessibility

Open-frame designs and accessible components allow for effective cleaning, inspection, and maintenance without unnecessary downtime.

3. Line Clearance

Systems are designed to enable fast and reliable line clearance, reducing the risk of cross-contamination between batches.

4. Product Quality and Integrity

Careful handling, controlled movements, and stable system operation ensure consistent product quality throughout the packaging process.

GMP Documentation Support

In addition to machine design, we support clients with the documentation required for GMP compliance and validation processes.

Master Documentation

  • User Requirement Specification (URS)
  • Functional Design Specification (FDS)
  • Hardware Design Specification (HDS)
  • Software Design Specification (SDS)

System Documentation

  • Electrical schematics
  • Pneumatic diagrams
  • Layout drawings (2D & 3D)
  • Equipment manuals

Operational Documentation

  • Standard Operating Procedures (SOPs)
  • Maintenance procedures
  • Cleaning procedures

Validation Documentation

  • Validation plans
  • IQ / OQ protocols
  • Test scripts and reports

Batch & Production Documentation

  • Batch records
  • Process documentation
  • Change control documentation

Designed for Compliance and Operational Efficiency

GMP design is critical to ensuring that packaging systems meet regulatory expectations while maintaining operational efficiency.

By integrating GMP principles at the design stage, we help manufacturers:

  • Reduce contamination risks
  • Improve cleaning and maintenance efficiency
  • Ensure consistent product quality
  • Simplify validation and compliance processes

Design Your Packaging System with GMP in Mind

Our team can help ensure your packaging systems are designed for compliance from the ground up.

Design for GMP Contact Form

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