Vial Seal Ordering FAQs: MOQ, Lead Times, Samples, Packing and Documents

Question 1

Is the minimum order counted per size and colour or per order?

Accepted Answer

Per size and colour. The minimum is counted per size and colour, and is confirmed with the quotation. A standard design is one of the existing FlipTop Optima, Pull Ring, Tear-Down or tear-off designs in a standard size and colour. The minimum applies to each size and colour combination, not to the order as a whole.

Question 2

Does a custom colour, print or emboss raise the minimum order?

Accepted Answer

A custom colour, print or emboss can change the minimum, which is confirmed with the quotation. Autofits offers a wide range of colours, matte or glossy, customised to requirement, and the quotation states the minimum for the exact combination of design, size and decoration requested.

Question 3

What is the lead time for standard seals?

Accepted Answer

The lead time for standard designs is confirmed with the quotation, counted from order confirmation. Order confirmation means the specification, quantity and delivery form have been agreed. The confirmed dispatch date for a particular order is given when it is placed.

Question 4

Why does a custom colour or printed order take longer than a standard one?

Accepted Answer

Because the artwork or colour has to be approved first, and that approval is part of the lead time stated with the quotation. The artwork or colour reference is approved before production begins, so the fastest route is to send the final artwork, the colour sample or reference and the text to be printed with the enquiry, rather than revising them after the order is placed.

Question 5

Does Ready-to-Use supply change the lead time?

Accepted Answer

It does: Ready-to-Use supply adds sterilisation and release to the lead time for the design ordered, confirmed with the quotation. The added time covers sterilising the packed seals by gamma irradiation or ethylene oxide and releasing that lot.

Question 6

Can I get samples before ordering?

Accepted Answer

Yes. Samples of standard designs are available; the quantity and dispatch date are confirmed on request. To get the right sample, state the design, size, colour, finish and delivery form, and the vial or bottle and stopper it will be used with, so the sample can be checked on your own capping line.

Question 7

What does a first order involve?

Accepted Answer

A first order usually runs in five steps: an enquiry with the vial neck, design and quantity; the controlled drawing and quotation; samples for a capping trial and your own testing; supplier qualification, including certificates and any audit your policy requires; and the purchase order against the approved specification. Standard designs shorten the process because the drawing already exists.

Question 8

What information does a quotation need?

Accepted Answer

A quotation needs the product line and design, the size, the colour and finish, any print or emboss artwork, the delivery form (Regular, Ready-to-Sterilize or Ready-to-Use), the annual or order volume, and the delivery destination. Add the stopper and vial neck drawings, so the seal drawing can be checked against the stopper it will close. With those, the drawing and a quotation stating the minimum and lead time can be prepared.

Question 9

How many seals go in each shipper box, and how are they bagged?

Accepted Answer

Seals are bagged and packed in a shipper box measuring 420 × 270 × 320 mm. Standard packing is 15,000 seals per box at 13 mm in three bags of 5,000, 6,000 per box at 20 mm, 3,000 per box at 28 mm in two bags of 1,500, and 1,400 per box at 32 mm in two bags of 700. The pack for 34 mm and for any special design is confirmed on enquiry.

Question 10

Is Tyvek or double bagging available?

Accepted Answer

Both are. Tyvek bagging is available on request, and double bagging is used for seals that go into aseptic areas, which includes all Ready-to-Use supply. The bag configuration for an order is stated with the quotation, alongside the box quantity for the size.

Question 11

How do ROPP cap carton counts compare across the five sizes?

Accepted Answer

Carton counts for pilfer-proof ROPP caps depend on size, shell height and liner. Carton counts for pilfer-proof caps depend on size, shell height and liner, and are confirmed with the quotation. The count and carton size for your order are confirmed with the quotation.

Question 12

Does Autofits ship outside India?

Accepted Answer

It does. Autofits manufactures in Nashik, Maharashtra, and supplies more than 150 pharmaceutical companies across India and export markets. For an export order, include the destination country and any documentation your import or regulatory process needs with the enquiry, so packing, paperwork and the delivery date can be confirmed with the quotation.

Question 13

Which certificates can I get with an order?

Accepted Answer

Autofits holds ISO 9001:2015 (21.GGCS.IN.091174), ISO 14001:2015 (21.GGCS.IN.140169) and ISO 15378:2017 (21.GGCS.IN.151175), Drug Master File 18100 and a CFDA registration. Certificate copies are supplied on request. Material declarations cover the AA8011 aluminium, epoxy lacquer and polypropylene, heavy metals at a maximum of 100 ppm total, and BSE/TSE status.

Question 14

How do I get a BSE/TSE certificate for seals?

Accepted Answer

Ask for it with the enquiry or the order. Autofits seal components are declared BSE/TSE-free against EMA's note for guidance EMEA/410/01 rev.3, and the declaration is supplied on request with the other certificate copies. If your quality system asks for an animal-derived-ingredient-free statement in a particular wording, send that wording with the request so it can be reviewed.

Question 15

How is seal batch traceability kept for audits?

Accepted Answer

Autofits works under an ISO 15378:2017 quality system, which includes requirements for identification and traceability. For your side of the audit, record the Autofits batch reference against each delivery at goods receipt; India's revised Schedule M, for example, requires each delivery or batch of primary packaging material to be given a reference number. That lets a filled product batch be traced to the seal lot used.

Question 16

Can a buyer audit Autofits as a supplier?

Accepted Answer

Supplier audits are a normal part of qualifying a primary packaging supplier. India's revised Schedule M expects suppliers of packaging materials to be evaluated before approval, with an audit where required, and ISO 15378 includes a subclause on customer audits. To arrange an audit of the Nashik facility, raise it through the contact page with your proposed scope and dates.

Question 17

How are changes to a seal notified?

Accepted Answer

Change control is part of the ISO 15378 quality system Autofits is certified to, which defines it as documented control of changes with appropriate risk management. How and when changes to materials, process or site are notified to a customer is agreed in the quality agreement for that supply, so include your change notification requirements in the agreement at qualification.

Question 18

What AQL are seals inspected to?

Accepted Answer

Standard AQL is critical nil, major not more than 2.5% and minor not more than 4%, and it can be tailored to a customer's specification. Every seal also passes 100% high-speed camera inspection before packing. If your incoming inspection uses a different defect classification, send it with the enquiry so the AQL plan can be aligned in the specification.

Question 19

How is pricing quoted?

Accepted Answer

Prices are quoted per order against the specification, not from a price list. The main factors are the design and size, colour, print or emboss, delivery form, and the order volume. A quotation states the price together with the minimum order and lead time for the exact combination requested, so the specification sent with the enquiry determines what comes back.

Question 20

Does Autofits supply stoppers with its seals?

Accepted Answer

No. Autofits makes aluminium and aluminium-plastic vial seals and aluminium pilfer-proof caps only, and does not supply stoppers. The stopper comes from a stopper manufacturer. For a seal enquiry, send the stopper drawing or its nominal size and flange dimensions with the vial neck finish, so the seal can be matched to that stopper and confirmed in a capping trial.