Turnkey Projects

Propack provides end to end solutions for all your pharmaceutical formulation process & packaging needs. Our team of technical experts and professionals support your business right from the planning stage to commencing production. A one-stop solution in the pharmaceutical formulation industry for all your process and packaging worries i.e. tablet, capsule, liquid, oral, dry syrup, injectable and IV fluids, we equip your manufacturing line with the right systems to ensure maximum productivity. We employ the best technical knowledge to deliver effective sustainable results. From project planning, producing fabricating machinery to packaging materials for finished products, our aim is to meet all your project aspirations. Managing turnkey projects for some of the largest pharmaceutical manufacturing units; we design them as per WHO-GMP, USFDA, MHRA, TGA and cGMP norms & requirements. Our team provides valuable support and assistance even after project completion to ensure continued production and minimal down times. Our cost-effective solutions improve overall project efficiency ultimately improving performance. Our ingenious designs and ethical business practices have helped us make our mark on the global markets as well.

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Validations / Standards

We provide assistance to your validation team for generating Master Validation Documents like VMP, System Impact Assessment, Master Documentation Procedure, and Risk Assessment etc.

Qualification services comprises of following main stages:

Commissioning:

  • IQ, DQ, PQ & OQ
  • Safety Checks
  • Verification
  • Documentation package

Validation:

  • Validation Master Plan
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
  • Preparation of SOP
  • GMP Auditing and Gap Analysis

We follow following International Standards, Codes and Norms for Sterile Liquid Processing System as a primary requirement of CGMP practice.

  • Mechanical Standards
    • Vessels: ASME Sec. VIII Div.1, AD-Merkblatt, ASME BPE
    • Heat Exchangers: TEMA
  • GMP Standards
    • USFDA, WHO, cGMP, EHEDG, FDA, ASME (BPE), A 3, ISPE Baselines, ISO-14159
  • European Nations Stds FOR CE Marking
    • Vessel Design: EN – 13445
    • NDT Standards: EN – 1435, 895, 12517 & 571
    • Safety Standards: DS/EN 1050
    • Hygienic Design: B3 EN 1672 – 2
  • Qualification Documents & Execution Standards
    • ISPE Baselines Vol 5
  • Equipments Layout Standards
    • ISPE Baselines Vol.3
  • PIPING STANDARDS
    • (BPE) / SA 270
    • Utility: ANSI B 31.3
  • Automation Standards
    • GAMP5 & 21 CFR Part 11

Compliance & Formulation

We offer a whole range of custom formulation products using our state-of-the art R&D and production facility. We cover everything under cosmetics ranging from personal care products to color cosmetics.

We assure delivery of cosmetic formulations/products of the highest quality standards and meet all our customer expectations. Expertise in creating, developing, and producing bulk as well as finished products is our forte with contract manufacturing options too. We help transform your ideas of cosmetics to actual delivery of the product.

Don’t hesitate to contact us to learn more about our R&D process and the variety of services on offer with us

Expertise: Skin care, hair care, bath & body, professional product, Sun care cosmetic, colour cosmetic.

PROPACK provides a comprehensive range of compliance & regulatory services to the global cosmetic industries. As a trusted partner for clients, we deliver on time, within budget & to the highest quality standards, always striving to exceed expectations. We operate with a non-silo approach as one united team to offer a global solution to our clients, who value the clear communication & exemplary service they receive from the start.

If you’re not sure about your formulation, let our professionals review your formulation design. We can help with compatibility of the different ingredients used in your product and their correct concentration. We will let you know whether your formulation is suitable for upscaling, for outsourcing and for your desired packaging.

Documentations

Propack’s work culture is based on Documentation at each & every stage for maintaining High Quality Standards and Traceability. We Provide

  • Design Qualification
  • Installation Qualification
  • Operation Qualification
  • Performance Qualification
  • Test Certificates of Material
  • FAT certificate, PMI Test carried at various levels, Calibration Certificate, Electrical Wiring Diagram, etc.
  • Working/ Safety & Maintenance Manual.

R & D Trial Services

Propack has similar Pharma cleanroom facility and provides in-house trials, for providing solutions to most critical products. We can provide product trials and can help in developing products with formulation, dossier and other services.

Research and development (R&D) is vital to ensure you maintain your competitive advantage, and it’s important not only to explore new products and processes, but also to continually improve existing products. Pharmaceutical R&D machines and equipment must replicate the processes involved in full-scale production to allow for accurate trial or test results, yet they must have a form-factor and footprint that is more suitable for lab work or for use in smaller development lines. R&D equipment should be able to handle small batch sizes, and yet be able to scale up production results accurately, allowing full analysis and product quality metering.

At Propack we understand the importance of R&D to your success. We take the time to understand your requirements and to ensure we provide solutions that not only fit seamlessly within your existing R&D operation but enable you to achieve superior results. We can help you to navigate through the complex options available to bring you the best development equipment for your R&D environment.

Pilot Scale services

Propack has similar Pharma cleanroom facility and provides in-house trials, for providing solutions to most critical products. We can provide product trials and can help in developing products with formulation, dossier and other services.

Making the leap from R&D development to a commercial or pilot plant production facility requires expertise in process design, pilot scale-up, controls integration and plant fabrication.

Using your bench scale data, Propack will help you successfully complete design & build for your process technology through our thorough scale-up design process.

The pilot plant can provide critical technical knowledge of how to build a large-scale plant. Indeed, a properly engineered pilot plant delivers important insights. Discovering faulty assumptions and errors on a small scale can avoid financial, safety and technical risks in subsequent larger units.

A pilot plant essentially is an evolution of your product to increased scale. A pilot plant’s primary objective is to demonstrate chemical and physical stability of a new production technique. Propack provides Modern modeling software offers a quick and efficient way to find optimal design parameters.

Certifications

  • Material Test Certificates
  • Food Grade Certificates for all elastomers
  • Orbital Welding Parameters
  • Organ Purity Certificate
  • Welder Qualification Certificate
  • Bores coping photographs
  • Radiographic Test Documents
  • Calibration Certificates for all instruments
  • Technical catalogues and GA Drawings for components
  • P & ID
  • GA Drawing

Validations

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