Primary Packaging Consultant For Medical Devices – Operon Strategist

Primary packaging is the term used to assign the layer of packaging in direct contact with the

product or dosage form in simple words actually, it is the first packaging layer in which the 

product is stored. Primary packaging material means any single part of a container closure 

system, for example, containers, container liners, closures, closure liners, stopper oversells, etc.

Secondary packaging material is a packaging component that is not and will not be in direct 

contact with the dosage form.

STANDARD ON PRODUCT CONTAINERS & CLOSURE

Current Good Manufacturing Practice (cGMP) requirements for the control of drug product containers 
& closures comprise in 21 CFR Part 210 & 211. Drug Master Files are a mechanism that primary
packaging manufacturers can use to share confidential information with health authorities without 
disclosing that information to the pharmaceutical industry.

In the US, Drug Master File (DMF) is a submission to the US FDA that may be used to 
provide confidential detailed information about facilities, processes or articles used in 
the manufacturing, processing, packaging & storing of one or more human drugs. 
Drug master files are a mechanism that primary packaging manufacturers can use 
to share confidential information with health authorities without disclosing that 
information to the pharmaceutical industry.

We provide Primary Packaging Turnkey Project services 

that include the following:

• Primary Packaging Layout Design :Packaging Layout Design Is An Important Element While Setting Up A Manufacturing Unit. While Designing The Plant/Facility Layout, The Consideration Has To Be Given To The Regulatory Requirements, In Particular, The Cgmp Requirements. 
• Clean Room conceptualization For Primary Packaging Clean Room Helps In Establishing & Maintaining An Environment With A Low Level Of Environmental Pollutants Such As Dust, Airborne Microbes, Aerosol Particles & Chemical Vapors.
• Primary Packaging Process Validation: Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation. 

Read More  -  Primary packaging

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing

    2.     CDSCO Registration

    3.     FDA 510 k clearance

    4.     Continuous Improvement Program

    5.     Design Control Requirements

    6.     QMS Certification Services

    7.     Manufacturing Plant Layout Design

    8.     Primary Packaging Consultant

    9.    CE Marking Consultant 

 10. Combination Product

 11. Medical Device Design And Development 

 12. Clean Room Design Consultant

 13. ISO 13485 Certification

 14. ISO 15378 certification

 15. Medical Device Process Validation

 16. 21 cfr part 820

 17. 21 cfr part 210 and 211

 18. DMF submission

 19. CAPA Management

 20. TURNKEY PROJECT CONSULTANT

 21. Manufacturing Site Conceptualization