Pharmaceutical primary packaging
Primary packaging is an integral component of the final pharmaceutical product. Grade 1 packaging is in direct contact with pharmaceutical products, so their quality directly affects the quality of pharmaceutical products.
The role of primary packaging in pharmaceutical manufacturing
Ensuring primary packaging quality is a mandatory requirement for pharmaceutical manufacturers. Right from the stage of developing drug registration dossiers, the information of level 1 packages must be clearly mentioned about the category. Regarding suppliers, these suppliers must meet GMP for pharmaceutical packaging, 1SO 15378 or other equivalent standards.
During the production process, all grade 1 packages must be preserved, ensuring the same storage conditions for raw materials (active ingredients, excipients) , are sampled before going into production.
In the process of researching the stability that determines the shelf life of products, it is imperative to keep pharmaceuticals in the correct grade 1 packaging because they will directly affect to the research results.
Quality requirements for grade 1 packaging in pharmaceutical manufacturing
Due to direct contact with pharmaceutical products, primary packaging should be strictly controlled to avoid becoming a source of contamination for pharmaceutical products.
Besides sensory, qualitative, and physical criteria (length, thickness, size, etc.), the microbiological limit is the most important criterion to check and control for bags. Primary packaging. This is because of the direct physical contact between the grade 1 packaging and the medicine inside it.
In addition, for liquid pharmaceuticals, the issue of contamination from the packaging is also concerned. Example: Glass packaging needs to be tested for the strength of the inner surface of the glass (according to the Vietnamese Pharmacopoeia V).
Primary packaging is commonly used in pharmaceutical manufacturing
Depending on the different dosage forms, it will be suitable for different grade 1 packaging. The most commonly used primary packages depend on the popularity of those dosage forms in the market.
Collectively, the types of primary packaging commonly used in pharmaceutical manufacturing include:
Printed aluminum film, PVC film, PVC/PVDC film, profiled aluminum film, blister aluminum film
Membrane transplantation
Glass bottles
Plastic bottles
PGA . Grade 1 packaging products
PGA Primary Packaging Joint Stock Company was built with the purpose of providing a wide range of GMP primary packaging products to customers. In the first phase, PGA’s products focus mainly on pharmaceutical packaging, oral solid and liquid TPBVSK including:
- Glass bottles (type III) containing products solid and liquid products
- Plastic bottles for solid and liquid products</ a>
- Printed aluminum film for aluminum-PVC, aluminum-aluminum blister pressing
- PVC, PVC/PVDC film for blister pressing
- PVC/PE film for drinking tube closing purposes
- Aluminium-formed film for aluminum-aluminum blister pressing
- Tear-tear aluminum film for blister press
We are committed to providing complete packaging solutions at a reasonable cost and innovative services, meeting the unique needs of each business.< /p>
For details please contact:
PGA Level 1 Packaging Corporation
Headquarters: Lot A29, An Phat High-Tech Industrial Park, Km47, National Road5, Viet Hoa Ward, City. Hai Duong, Hai Duong Province
Hotline: 0902256903