Sigma Jet + CFR: The 21 CFR Part 11 Compliant Induction Cap Sealer
Our fastest 100 feet-per-minute automatic inline sealing equipment, plus the full compliance layer for regulated, high-volume lines. Electronic records, electronic signatures and a full audit trail are part of the machine, not an add-on.
Manufactured on the same platform as the standard Sigma Jet: 20 to 120 mm caps, a 100% air-cooled coil, fully assembled on delivery. Do not need FDA compliance? See the standard Sigma Jet.
100 FPM
Line Speed
21 CFR
Part 11 / ERES
20 to 100 mm
Cap Range
100%
Air Cooled
100 FPM
Max Line Speed
21 CFR Part 11
ERES Compliant
20 to 100 mm
Cap Diameter Range
415 V
Three Phase, 50/60 Hz
100% Air Cooled
Waterless, Ambient Temp
PLC + HMI
Recipe, Reject, Audit Trail
The Flagship Sealer for High-Speed Lines
At the top of the Sigma lineup for output, the Jet runs 100 feet per minute and ships fully assembled, so it fits most lines without modification. The frame is self-standing and the machine is with castor wheels.
Output is only half the story. Every seal it makes is recorded. The customer can store the recipe of the production behind a password, rejects are counted, and the data lands in an audit trail that holds up to FDA scrutiny. The machine that runs your line fastest is also the one that keeps your quality team covered.
How the Sigma Jet Works
An induction sealer bonds a foil liner to the container mouth via an electromagnetic field, and a 21 CFR Part 11 compliant machine records every seal as it goes. The Sigma Jet does that at up to 100 feet per minute, so you get the desired output and the record in the same pass.
1
Feed and Convey
Containers arrive already capped and pass under the sealing head at up to 100 feet per minute. It is a fully automated system.
2
Induction Seal
The coil generates an electromagnetic field to the foil liner as each bottle passes under it. The sealing head delivers a full wax melt, so you get hermetically sealed bottles.
3
Inspect, Reject and Record
Any missed seal is detected and rejected, shown on the touchscreen, and time-stamped to the audit trail.
4
Recipe Management and Electronic Signature
The customer can store the recipe of the production, and an electronic signature with a comment locks the run to the validated setting.
21 CFR Part 11 Compliance, Explained
Here is what 21 CFR Part 11 actually asks for, and how the Sigma Jet answers each point.
- What 21 CFR Part 11 requires
- How Sigma Jet + CFR does it
Electronic records (ERES)
It captures recipe, seal and reject data automatically for the run, with a time stamp on each entry.
Electronic signatures
Operators and supervisors sign off on recipes and changes, tied to their own login.
Audit trail
Settings, faults and rejects land in a searchable, time-stamped log you can pull for an inspection.
Access control
Supervisory password protection with operator lockout keeps unauthorised changes out.
Data integrity
The machine monitors its own critical operating data, so nothing depends on manual transcription.
Validation (IQ, OQ, PQ)
It ships fully assembled for predictable qualification, and the recorded data feeds your protocols. Documentation support is available.
In short: ERES means electronic records and electronic signatures. Sigma Jet + CFR builds both in, so you do not have to bolt a separate data-capture system onto the line later. This compliance layer is exclusive to the CFR variant; the standard Sigma Jet ships without it. For the full breakdown of the roles, users and audit events, see Inside the Compliance Engine below.
Inside the Compliance Engine
Role-Based Access Control
Five default roles are provided: Admin, Supervisor, Operator, Manager and Maintenance. Each has a defined scope, so your SOPs map onto the machine directly.
User Management
Create new users, assign roles and generate passwords for up to 100 users. Every account is individual, so there are no shared credentials on the line.
Pre-Defined Variables
Database backup location and backup frequency, password expiry, wrong-attempt limit, date and time formats, screen timeout, password complexity, password change at first login, database limit notification, archival, previous password limit and expiry notification. All preset based on discussion with the customer.
Audit Trail: What It Logs
Login and logout events, admin changes, user management, role management, access management, machine setting changes, alarms and electronic signature events. Time-stamped and searchable.
Reporting Suite
Three report types: Batch Report, Alarm Report and Audit Trail Report. QA pulls the audit trail ahead of an inspection; production pulls batch reports at release; maintenance pulls alarm reports for uptime.
Recipe & Batch Management
Up to 200 recipes can be created, plus batch settings, pack details such as bottle and cap, and recipe settings. Enough headroom for a multi-SKU line to treat changeover as routine rather than a risk event.
Electronic Signature & Comments
Electronic signature and comment are preset as per discussion with the customer. Every signature carries a comment field alongside the signoff.
Access Management
Default access levels are pre-defined as confirmed by the customer team, so the machine matches your existing authority matrix at go-live.
Machine Functionality
Batch view and line view, machine settings, machine functions such as start and stop, change of speed and parameters, enable and disable alarms, and interlocks, all on the same touch screen that runs the line.
Extend the Compliance Package
Everything above is included in the 21 CFR Part 11 compliance software. The following modules are available at extra cost where your site needs more capacity or finer control.
Capacity
- Additional users, in sets of 100
- Additional recipes, in sets of 100
Configurability
- Settable pre-defined variables, where the customer admin needs different values for different users
- Settable or configurable access management up to field level, for different user groups
Production Handling
- Repack and Rework module
- Re-processed batches carry the same audit trail and electronic records as a first-pass run
Tell your applications engineer how many users, recipes and access groups your site runs, and the quotation is scoped to that rather than to a standard bundle.
Key Features and Engineering Advantages
What you get when output and compliance live in the same machine.
100 FPM, Top of the Range
The fastest sealer in the lineup, and the only one manufactured with the compliance layer running alongside it at full output.
21 CFR Part 11 with ERES
Electronic records, electronic signatures and audit trails ready for FDA-regulated production.
Bottle Jamming Detectors
Detect backup of bottles at in-feed and out-feed, so a pile-up stops the line instead of running through the sealing head.
Bottle Counter
Automatically counts and displays the number of sealed and rejected bottles, and the count is written to the batch record.
Batch Processor
You can specify how many bottles you would like to seal in the batch.
No Foil Detector
Detects the presence or absence of an induction foil liner/wad in the cap/bottle.
No Cap Detector
Electronic signature and comment are preset as per discussion with the customer. Every signature carries a comment field alongside the signoff.
100% Air Cooled
The 100% air-cooled coil needs no water. There is no water circulation required and no utility to document for your qualification.
Universal Coil, Complete Wax Melt
One coil covers 20 to 120 mm, and the ultra-modern head melts the wax fully for a clean bond. We can provide a sealing head as per your diameter design.
Cap and Container Compatibility
The universal coil covers 20 to 120 mm across the closures, materials and liners most regulated lines run, without a hardware change between validated recipes.
Caps & Closures
- Child-resistant caps (CRC)
- Dome caps
- Sports caps and spout caps
- Snap-on caps
- Flip-top caps
- Standard continuous-thread screw caps
Container Materials
- HDPE and LDPE bottles
- PET containers
- PP containers
- Glass containers
- Plastic caps with a foil liner
- Induction liner depends on the types of bottles/container
Liners & Sealing Heads
- Two-piece foil induction liners
- One-piece foil induction liners
- Heat-seal wads matched to cap size
- Universal sealing head
- Tunnel/deep tunnel sealing head
- Customized sealing head for customized closures
Which Sigma Model Fits Your Line?
Pick by line speed and by whether you need full 21 CFR compliance. The Jet is the answer when you want both the highest output and an FDA-ready record.
- Model
- Type and Speed
- Best For
Sigma Flex
Manual, 4 to 8 bottles per minute
Lab, batch and startup work
Sigma Pro
Semi-automatic, 10 to 15 bottles per minute
Small batch production / lab production
Sigma Eco
Automatic inline, 20 bottles/min (25 ft/min)
Low production line (20 to 120 mm cap size)
Sigma I Neo
Low to mid output (cap size: 20 to 120 mm)
Low production line (20 to 120 mm cap size)
Sigma II Neo
Automatic inline, 55 ft/min
Mid to high volume (120 bottles/min)
Sigma II Neo Touch
Automatic inline, 55 feet per minute
Mid to high volume (touch panel with user and password, recipe management up to 5 recipes)
Sigma III Touch
Automatic inline, 80 feet per minute
High-volume GMP compliance
Sigma Jet
Automatic inline, 100 feet per minute
Maximum output (220+ bottles/min) with additional features; machine can be interlocked with existing conveyor
Automatic inline, 100 feet per minute
Maximum output (220+ bottles/min) plus full 21 CFR Part 11 compliance
Sigma Jet and Sigma Jet + CFR share the same 100 FPM platform. Choose CFR for FDA-regulated lines that need electronic records, e-signatures and a full audit trail; otherwise the standard Sigma Jet covers it.
Output and Cost of Ownership
100 FPM
Speed to Output
The conveyor moves at 100 feet per minute. Containers per minute depend on your bottle spacing and cap diameter. Give us your bottle & cap diameter and we will give you a number.
Built-In ERES
No Bolt-On Systems
Because records and signatures are part of the machine, you skip a separate data-capture layer and the validation work that comes with it. See Inside the Compliance Engine for what that layer actually covers.
No Chiller
Lower Running Cost
The 100% air-cooled coil needs no water. On-board inspection detects a missed seal before it enters the induction sealing equipment, which brings the cost per sealed bottle down further.
Inspection, Rejection and the Record Behind It
The touch screen watches the seal, drops the failures, and keeps a record of what happened, so you are never reconstructing a run from memory. For the full detail on roles, users and audit events, see Inside the Compliance Engine.
- Inspection and rejection of every seal, in line
- Supervisory password protection with operator lockout
- Recipe management: the customer can store the recipe of the production
- Descriptive faults and monitoring of all critical operating data
What Your Auditor Sees
A time-stamped trail of recipes, signatures, faults and rejects, pulled straight from the machine. That is the difference between passing an inspection and reconstructing it.
System
Password protected
Counters
Sealed and rejected
Trail
Time-stamped
Access
Password controlled
Where is Sigma Jet + CFR Applicable
A fast seal and a record that proves it, across regulated production lines.
Pharma & Healthcare
Tamper evidence, a moisture barrier, and a Part 11 audit trail on every bottle. Used by Sun Pharma and Dr. Reddy’s.
Nutraceutical
Recorded recipes bring every SKU changeover back to the validated setting.
Food & Beverages
A documented seal at full line speed. Used by Nestle, Tata Tea and ITC.
Dairy
Airtight seals with a logged batch record for recall traceback.
Lubricants & Break Fluid Oils
Clean seals on thick lube fills, with every recipe change tracked.
Agro Chemicals / Insecticide / Pesticide
Secure seals with electronic sign-off on every recipe. Used by Syngenta.
Petro Chemicals
Reliable foil seals with the record to back them up.
Personal Care
Leak protection, theft evidence, and a signed-off recipe history. Used by Alpla.
Specialty Chemicals & Adhesives
Solvent-tight foil seals on adhesives, resins and specialty chemical packs, with the batch record to match.
Power and Line Integration
The one planning item is three-phase power, same as every model at this speed tier. Once that is confirmed, installation and IQ can move forward in the same visit.
- Operates on 415 ± 10% V AC, three phase, 50/60 Hz — have this confirmed before your IQ date
- Fully assembled — ready to slot into most existing lines, which keeps installation qualification straightforward
- Standalone equipment
- Castor wheels for positioning, station pads to lock the final location for validation
- Coil head moves 350 mm vertically, with a height indicator and lock so the qualified position does not drift
Built to Qualify Fast
Our applications team confirms power and layout ahead of delivery, and can support your IQ documentation from day one. The machine can be interlocked with your existing conveyor.
415 V
Three phase
350 mm
Coil movement
Assembled
Installation ready
Castor
Wheeled frame
Sigma Jet + CFR Technical Specifications
- Parameter
- Sigma Jet + CFR Specification
Machine Type
High-speed automatic inline induction cap sealer, GMP compliant model
Compliance
USFDA 21 CFR Part 11, electronic records and electronic signatures (ERES)
Max Line Speed
100 feet per minute
Cap Diameter Range
20 mm to 120 mm, universal sealing coil
Sealing Coil Height Movement
350 mm, with height indicator and position lock
Cooling
100% air-cooled, waterless, ambient temperature operation
Power Electronics
IGBT solid-state
Control
PLC controlled with touch-screen HMI
Recipe Storage
Up to 200 recipes (additional recipes available in sets of 100)
User Accounts
Up to 100 named users, role-based (Admin, Supervisor, Operator, Manager, Maintenance); additional users available in sets of 100
Reports
Batch Report, Alarm Report, Audit Trail Report
Pre-Defined Variables
DB backup location and frequency, password expiry and complexity, wrong-attempt limit, date/time formats, screen timeout, password change at first login, database limit notification, archival, previous password limit, expiry notification
On-Board Functions
Bottle jamming detectors, bottle counter, batch processor, no foil detector, no cap detector, recipe management, password protection, audit trail, data monitoring
Sealing Head
Ultra-modern, complete wax melt; universal, tunnel/deep tunnel and customized options
Construction
Stainless steel, self-standing, castor wheels, station pads, ships fully assembled
Sealing Head
415 ± 10% V AC, three phase, 50/60 Hz
Safety
Over-voltage, over-current and over-temperature protection, conveyor stop and alarms/E-stop
Optional Modules
Additional users (sets of 100), additional recipes (sets of 100), settable pre-defined variables per user, configurable access management to field level, Repack and Rework
Choose the liner according to bottle type. The liner should be compatible with the bottle/container, and the sealing head is supplied as per your closure. For validation support and integration help, talk to Sigma CapSeal applications engineering.
50+
Years of Experience
85+
Countries Served
250+
Engineers on the Team
2015
Best Pac Machine Award
Backed by 35 Global Service Centers
DSIR-certified R & D and 35 global service centers stand behind every Jet, wherever your plant is. Customer support via video call available.
Why Choose Sigma Jet + CFR
Sigma CapSeal has manufactured heating equipment since 1974 and manufactured India’s first indigenous induction sealer in 1989. A DSIR-certified R & D lab, a 99% on-time delivery record, and equipment running in more than 85 countries back the compliance layer as much as the hardware — a sealer you can validate, with a record you can defend at inspection. Customer support via video call available.
Trusted by leading manufacturers worldwide
Nestle
Sun Pharma
Dr. Reddy’s
Tata Tea
ITC
Syngenta
Alpla
Frequently Asked Questions: Sigma Jet + CFR
What pharma manufacturing heads, QA managers, packaging engineers and procurement teams ask before they buy.
What makes the Sigma Jet + CFR 21 CFR Part 11 compliant?
It captures electronic records and signatures, keeps a time-stamped audit trail of settings, faults and rejects, and locks access behind operator and supervisor passwords.
How fast is 100 FPM in containers per minute?
The conveyor runs at 100 feet per minute; the container count depends on your bottle spacing and cap diameter. Give us your bottle & cap diameter and we will give you a number for your validation protocol.
Is it water-cooled or air-cooled?
100% air-cooled. There is no water circulation required, so there is no chiller and no water line to qualify or maintain. One less utility to document in your IQ.
How many user accounts and roles does the Sigma Jet + CFR support?
Up to 100 individual user accounts across five roles: Admin, Supervisor, Operator, Manager and Maintenance. Each role has a defined permission scope, so access control maps onto your existing SOPs instead of the other way around.
Can access levels and password policy be configured for our site?
Yes. Default access levels are pre-defined as confirmed by your customer team, and the pre-defined variables, including password complexity, expiry and wrong-attempt limits, are preset based on discussion with you. Settable variables per user and access management down to field level are available as optional modules.
Does the electronic signature include comments, or just a signoff?
Both. Electronic signature and comment are preset as per discussion with the customer, so every signature carries a comment field alongside the signoff.
What is included as standard, and what costs extra?
Role management, user management for up to 100 users, pre-defined variables, the three reports, the audit trail, machine functionality, batch and recipe settings for up to 200 recipes, access management and electronic signature with comments are all included in the 21 CFR Part 11 compliance software. Additional users, additional recipes, settable variables per user, configurable access management to field level, and the Repack and Rework module are optional at extra cost.
How is it different from the standard Sigma Jet and the Sigma III Touch?
Same 100 FPM platform as the standard Sigma Jet, with the full 21 CFR Part 11 compliance layer added. The Sigma III Touch is single phase while the Sigma Jet is three phased, and it runs at 80 feet per minute with no compliance layer.
Does it need three-phase power?
Yes. The Jet operates on 415 ± 10% V AC, three phase, 50/60 Hz, so plan a three-phase supply at the install point. See Power and Installation.
Can it be validated with IQ, OQ and PQ?
Yes. It ships fully assembled for predictable qualification, and the recorded data feeds your protocols. Ask our team about validation documentation support.
What does the Sigma Jet + CFR's audit trail actually record?
Login and logout events, admin changes, user management changes, role management changes, access management changes, machine setting changes, alarms, and electronic signature events. All of it is time-stamped and searchable.
How many recipes can the Sigma Jet + CFR store?
Up to 200 recipes can be created, and the customer can store the recipe of the production. Additional recipes are available in sets of 100 as an optional module.
What reports can we pull for an FDA inspection?
Three: the Batch Report, the Alarm Report and the Audit Trail Report. QA typically pulls the Audit Trail Report ahead of an inspection, production uses the Batch Report at release, and maintenance uses the Alarm Report to track line uptime.
Can access management be configured down to field level?
Yes, as an optional module. The standard package provides default access levels pre-defined with your team; the optional module makes access settable or configurable up to field level for different user groups.
Spec a Sigma Jet + CFR for Your Line
Tell us your cap and liner, your target speed, and your compliance needs. An applications engineer will confirm the fit, the head, the electrical supply and the validation support before you commit.