CCIT Positive
Control Samples

Laser-drilled reference standards for qualifying leak-testing equipment. Flow-calibrated, NIST-traceable, USP <1207> compliant – shipped globally.

Trusted by
90+ Drug Manufacturers Globally

What are
CCIT Positive Controls?

Regulatory bodies including FDA and EMA require Container Closure Integrity Testing for sterile pharmaceutical products. Positive controls verify that your detection system can actually detect a leak- they are mandatory for CCIT method validation.

SSI’s CCIT samples can be used for the following methods:

Helium Leak
Vacuum Decay
Headspace Analysis
Dye Ingress

Regulatory Requirement

Required under USP <1207> and ICH guidelines. FDA expects validated CCIT methods with proven positive controls for all sterile injectables and inhalation products.

Precision Laser Drilling

Holes are created by calibrated laser machines. Shape is tapered (large outside, small inside) – closely mimicking real container defects like cracks and pinholes.

Traceable Certification

Every batch ships with a flow-calibrated Calibration Certificate. Each unit is individually serialized and measured with a mass flow meter traceable to NIST standards.

All Container Types

Available for glass vials, ampoules, cartridges, pre-filled syringes, plastic bottles, and eye-drop containers. Send your empties and we laser drill to specification.

Fast Turnaround

Glass containers under 500 pcs: 1–2 weeks from receipt of your samples. Above 500 pcs: 2–3 weeks. Lead time starts from receipt of empty containers, not order date.

Global Supply

We export to pharma manufacturers across Asia, Europe, Middle East, and the Americas. Shared shipping arrangements keep freight costs competitive for your validation budget.

Our Capabilities

Container Types We Drill

Glass Vials

Pre-filled Syringes

Cartridges

Ampoules

Plastic Bottles

Eye Drop Containers

Plastic

Micropipette / Capillary

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What to Expect When You Order

We supply laser-drilled positive controls across three product categories. Pricing varies by volume- the more you order in a single PO, the better the rate. Contact us for a quote based on your exact specification.

Supplies

Tier

Glass

Plastic

Micropipette /  Capillary

Micropipette / Capillary Implant

Standard

< 50 pcs

<200 pcs

Bulk

50–500 pcs

>200 pcs

Volume

> 500 pcs

–

Tier

Standard

Bulk

Volume

Glass

< 50 pcs

50 – 500 pcs

> 500 pcs

Plastic

< 50 pcs

50–500 pcs

> 500 pcs

Micro pipette /Capillary

> 200 pcs

–

Micro pipette /Capillary Implant

< 200 pcs

> 200 pcs

–

Lead Time

Order Size

Lead Time

Under 500 samples

4 weeks

Above 500 samples

4 – 6 weeks

Rush order

Faster lead time available on request

Optional add-ons:

Engraving

Unique identification marking per unit, for full sample-level traceability through your qualification study.

Certificate with photographic evidence

Each certificate accompanied by a photograph of the specific sample.

Every Order Ships with a Calibrated Certificate

Each container is individually measured and documented. Standard Calibration Certificate is included in your order at no additional cost – microscope image version available as an add-on.

Unique serial number per individual unit
Nominal diameter and tolerance (µm)
Measured flow rate in sccm
Calculated effective orifice diameter
Measurement uncertainty Rrel (k=2)
NIST-traceable mass flow meter calibration
Calibration date and reviewer signatures
Microscope images available as add-on

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Frequently Asked Questions

What are CCIT Positive Control containers used for?

They are used for qualification, requalification and routine challenge testing of container-closure integrity testing equipment. SSI supplies laser-drilled defects as small as 1 micron, with traceability and documentation including a Certificate of Conformance and Quality Data Sheet.

Can SSI drill a hole at a specific location on our container?

Yes. SSI can drill a specified hole size and location once the container drawing/details are confirmed.

Can you certify defect size and location for molded containers with variable wall thickness?

Yes. SSI can issue certification while taking the customer’s specified wall-thickness range into account.

What hole sizes can SSI provide for CCIT positive controls?

SSI can provide laser-drilled holes down to approximately 1 micron. The appropriate defect size should be selected based on the customer’s CCIT method, equipment and qualification protocol.

Can SSI provide CCIT positive controls for our exact container-closure system?

Yes, subject to technical feasibility. SSI can work from the customer’s container drawings, material and closure configuration to define the appropriate positive-control specification.