Vial therapy production

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 At Solaris the manufacturing of sterile injectable drugs that are filled and sealed in glass vials under a lot of restricted procedures to insure the safety, stability, and regulatory compliance of products .

• Liquid injectables 
• Lyophilized (freeze-dried) powders 
• Single-dose or multi-dose vials

• API (Active Pharmaceutical Ingredient) and excipients are sourced.
• Materials are tested for purity, identity, and compliance with pharmacopeial standards 

• At Solaris Ingredients are mixed under controlled conditions (often in stainless steel tanks ).
• Includes pH adjustment, buffer addition, and ensuring isotonicity.
• Done in a cleanroom environment .

• The solution is passed through a Dual filtration to remove microbes. 

• At Solaris The sterile solution is transferred into pre-sterilized glass vials using filling machines.
• Fill volumes are precisely controlled.

• A rubber stopper is placed on each vial immediately after filling to maintain sterility.
• Aluminum caps are crimped to secure the stopper.

• Terminal sterilization: Autoclaving filled vials if the product is heat-stable.

• Visual inspection for particulates, fill volume, and cosmetic defects.
• Leak testing, container closure integrity testing (CCIT).
• Batch is quarantined until passing quality assurance (QA) review.

• Labels applied with batch number and expiration date.
• Vials are packed into trays or boxes under GMP conditions.
• Temperature-sensitive products may be packed with cold chain protocols (2–8°C or -20°C).

• GMP Compliance is mandatory (Good Manufacturing Practices).
• Regulatory Oversight: FDA (U.S.), EMA (Europe), MHRA (UK), etc.
• Validation: All equipment, processes, and personnel must be validated and regularly audited.
• Cleanroom Design: Pressurized zones, HEPA filters, controlled humidity/temperature.

At Solaris we depend on restricted qualification:

• GMP Compliance is mandatory (Good Manufacturing Practices).
• Regulatory Oversight: NFSA
• Validation: All equipment, processes, and personnel must be validated and regularly audited.
• Cleanroom Design:Using HEPA filters, controlled humidity/temperature.

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