Vial Seals for Egypt
Autofits supplies FlipTop® flip-off seals, all-aluminium tear-off and tear-down seals and aluminium pilfer-proof caps to drug makers in Egypt from its plant in Nashik, India. The Egyptian Drug Authority (EDA) asks every registration dossier to describe each primary packaging component by its materials, its specification and its critical dimensions, and Autofits holds that data for every seal it makes, under ISO 15378:2017 and Drug Master File 18100.
Key takeaways
- Regulator: the Egyptian Drug Authority reviews registration dossiers in the CTD format.
- What it asks of a seal: materials of construction, specification and critical dimensions with drawings, in Module 3 section 3.2.P.7.
- Suitability: section 3.2.P.2.4 asks why the closure suits the product, and for sterile products the integrity of the container closure.
- What Autofits holds: drawings with tolerances, material specifications, ISO 15378:2017, ISO 9001:2015, ISO 14001:2015, DMF 18100, BSE/TSE statement.
- Range: 13 to 34 mm seals and 22 to 38 mm ROPP caps, Regular, Ready-to-Sterilise or Ready-to-Use.
- In Cairo: Autofits exhibited at Pharmaconex Egypt 2026, 1 to 3 September 2026, Egypt International Exhibition Center.
What the Egyptian Drug Authority expects of a primary packaging component
The EDA’s Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals (version 2, March 2023) asks for a description of the container closure system, including the identity of the materials of construction of each primary packaging component and its specification. The specification has to include a description, identification and critical dimensions, with drawings where appropriate. This sits in section 3.2.P.7 of the dossier.
The same guideline asks, in section 3.2.P.2.4, for a discussion of why the container closure suits the product: the choice of materials, compatibility of the materials with the dosage form, including sorption and leaching, the safety of the materials, and performance. For sterile products, section 3.2.P.2.5 asks the applicant to address the integrity of the container closure in preventing microbial contamination. The guideline names the WHO guidance on multisource products and the US FDA guidance on container closure systems as its references.
The drug maker prepares and files the dossier. A seal supplier’s job is to give it the data for those sections, accurately and with document numbers it can quote.
What Autofits holds against each requirement
| EDA dossier requirement | What Autofits holds |
|---|---|
| Materials of construction (3.2.P.7) | AA8011 aluminium to EN 15088:2005; epoxy lacquer to 21 CFR 175.300; polypropylene to FDA 21 CFR 177.1520 and EC 1895/2005 |
| Specification and critical dimensions, with drawings (3.2.P.7) | Engineering drawings with tolerances for every FlipTop, tear-off and tear-down seal size |
| Safety of materials (3.2.P.2.4) | BSE/TSE-free to EMEA/410/01 rev. 3; heavy metals maximum 100 ppm total; BADGE, NOGE and BFDGE not used |
| Integrity for sterile products (3.2.P.2.5) | Seals made to ISO 8362-6 (aluminium-plastic) and ISO 8362-3 (all-aluminium); the drug maker verifies integrity on the capped vial |
| Quality system of the component maker | ISO 15378:2017 (21.GGCS.IN.151175), ISO 9001:2015 (21.GGCS.IN.091174), ISO 14001:2015 (21.GGCS.IN.140169) |
| Packaging data a regulator can review | Drug Master File 18100 |
Certificate copies and declarations are supplied on request. How a customer verifies closure integrity on the filled vial is covered under container closure integrity testing, and the whole list of standards in the regulatory compliance pack.
The range for Egyptian drug makers
| Product | Sizes | Common use |
|---|---|---|
| FlipTop® Optima | 13, 20, 28, 32, 34 mm | Injectable vials with a retained needle port |
| FlipTop® Pull Ring | 20, 32 mm | Oral medicines, often marked “For Oral Use Only” |
| FlipTop® Tear-Down | 13, 20, 32 mm | Oral vaccinations |
| Tear-off seals | 13, 20, 32 mm | All-aluminium seals removed by tearing |
| Pilfer-proof caps | 22, 25, 28, 35, 38 mm | Pharmaceutical bottles |
FlipTop seals come Regular, Ready-to-Sterilise or Ready-to-Use, gamma or ETO sterilised and double-bagged, in glossy, matte, embossed or printed finishes. Shipper boxes are 420 × 270 × 320 mm; counts per box are on the packaging and shipping page.
Autofits at Pharmaconex Egypt 2026
Autofits exhibited at Pharmaconex Egypt 2026, held from 1 to 3 September 2026 at the Egypt International Exhibition Center in Cairo, at Hall 10, stand F20. The company’s Managing Director, Director and Chief Executive Officer were listed to attend, and the solutions presented were the FlipTop range, the all-aluminium seals, pilfer-proof caps and Ready-to-Use and Ready-to-Sterilise supply.
In practice at Autofits
Seals for Egypt are made at the same Nashik plant as every other order: a 75,000 sq ft site with ISO Class 8 cleanroom assembly, in-house polypropylene moulding and 100% high-speed camera inspection. Autofits Packaging Pvt. Ltd. holds Importer-Exporter Code 0310003130. The plant is described on the factory page and the quality system on the quality page.
Frequently asked questions
What does the Egyptian Drug Authority require for a vial closure?
The EDA’s CTD quality guideline asks for the materials of construction of each primary packaging component, its specification and its critical dimensions, with drawings where appropriate, in section 3.2.P.7. Section 3.2.P.2.4 asks why the closure suits the product, including compatibility and safety of the materials.
Does Autofits supply vial seals to Egypt?
Yes. Autofits supplies FlipTop flip-off seals, all-aluminium seals and pilfer-proof caps to drug makers outside India from its plant in Nashik, and exhibited at Pharmaconex Egypt 2026 in Cairo.
Does Autofits have a Drug Master File?
Yes, Drug Master File 18100, held alongside ISO 15378:2017, ISO 9001:2015 and ISO 14001:2015 certification.
Which seal sizes are used on vials in Egypt?
The common injectable vial necks are 13 and 20 mm, with 28, 32 and 34 mm for larger vials. Autofits makes the FlipTop Optima in all five, and the size follows the vial neck finish set by ISO 8362-1.
Are Autofits seals BSE/TSE-free?
Yes. Components are free of materials of animal origin and comply with EMEA/410/01 rev. 3.
Sources
- Egyptian Drug Authority: Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals, version 2, 2023
- ICH: M4Q, The Common Technical Document, Quality
- Autofits FlipTop Seals dossier, engineering drawings and company records
*Last updated: 2026-11-06. Product and supply information only, not regulatory advice.*
