Biological Indicators for Ethylene Oxide Sterilization Processes
Employees State Insurance Corporation
HYDERABAD, TELANGANA
Posted:
28 August 2025
Closed:
22 September 2025
GEM
GEM
Banaras Hindu University Biological Indicators for Ethylene Oxide Sterilization Tender Varanasi UP 2026 ISO 13485 MDR IS/ISO 11138-1
Bid Publish Date
06-Jun-2026, 5:43 pm
Bid End Date
20-Jun-2026, 6:00 pm
EMD
₹18,000
Location
Progress
Issue06-Jun-2026, 5:43 pm
AwardPending
Quantity
1000
Bid Type
Two Packet Bid
Categories
8
Tender Overview
Banaras Hindu University (Department Of Higher Education), Varanasi, Uttar Pradesh invites bids for Biological Indicators for Ethylene Oxide Sterilization. The procurement includes compliance with IS/ISO 11138-1 (Latest Revision), requirement for MDR 2017 compliance, and a valid medical device license under the Drug and Cosmetic Act. The supplier must hold ISO 13485 (Latest) for the manufacturing unit and provide batch test reports per MDR. An EMD of ₹18,000 applies, with advance sample provision requested prior to supply. The buyer reserves the right to adjust quantities by up to 25%, with extensions as per contract terms. This tender addresses a specialized sterilization process control product line and emphasizes regulatory and quality certifications.
Technical Specifications & Requirements
- Product shall comply to IS/ISO 11138-1 (Latest Revision) for biological indicators used in EO sterilization.
- Conformity to MDR 2017, as amended; supplier must provide test reports for each batch per MDR.
- Valid drug/medical device license under Drugs & Cosmetic Act 1940 as amended.
- ISO 13485 (Latest) certification for the manufacturing unit.
- Shelf life from date of manufacture (in months) and minimum shelf life at delivery clearly specified.
- Advance sample to be provided for buyer approval before commencing supply.
- All relevant certifications, licenses, and test reports must be submitted at bid submission or with supplies as per buyer requirement.
Terms, Conditions & Eligibility
- EMD: ₹18,000.
- Option clause: Purchaser may increase/decrease quantity up to 25% of bid quantity, with extended delivery as defined.
- Bidder must show sound financial standing (no liquidation or bankruptcy) and upload an undertaking.
- Queries via GeM portal only; physical demonstration may be required.
- Delivery period, penalties, and terms to be as per buyer added ATC clauses and standard GeM terms.
Key Specifications
-
Product: Biological Indicators for Ethylene Oxide Sterilization
-
Standards: IS/ISO 11138-1 (Latest Revision)
-
Compliance: MDR 2017 with up-to-date amendments
-
Certifications: ISO 13485 (Latest) for manufacturing unit
-
Licenses: Drug/Medical Device License under Drugs and Cosmetic Act 1940
-
Test Reports: Batch-wise MDR-compliant test reports
-
Shelf Life: Months from manufacture date; minimum shelf life at delivery
-
Advance Sample: Required prior to supply
-
Delivery: As per contract terms with 25% quantity variation allowance
Terms & Conditions
-
EMD of ₹18,000; bid must include valid EMD submission
-
Quantity may vary up to 25% during and after contract
-
Bidder must hold MDR-compliant licenses and ISO 13485
-
IS/ISO 11138-1 compliance and batch MDR test reports required
-
GeM portal queries only; possible physical demo
Important Clauses
Payment Terms
Payment terms to be governed by GeM/Tender ATC; details to be confirmed in ATC document
Delivery Schedule
Delivery period linked to original delivery order with extension as per option clause; minimum 30 days for additional time
Penalties/Liquidated Damages
LD provisions to be as per ATC and GeM terms; non-delivery penalties may apply
Bidder Eligibility
-
Not under liquidation, court receivership, or bankruptcy
-
Demonstrable experience in supplying sterilization indicators or related medical devices
-
Valid MDR compliance, Drug/Medical Device license, and ISO 13485 certification
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Biological Indicators for Ethylene Oxide Sterilization Processes (Q2)
Authority Records
MINISTRY OF EDUCATIONHIGHER EDUCATION DEPARTMENT
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GeM Registration
Document Filing
Free consultation · 24h response
Documents 5
GeM-Bidding-9432784.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
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Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL | Product Description | Biological Indicators for Ethylene Oxide Sterilization Processes |
| STANDARD | Conformity to Standand | IS/ISO 11138-2 (Latest Revision) |
| PRODUCT INFORMATION | Product Shall Comply to the General requirments of IS/ISO 11138-1 (Latest Revision) | Yes |
| PRODUCT INFORMATION | Type | Self-Contained |
| PRODUCT INFORMATION | Test organism | Spores of Bacillus Atrophaeus |
| PRODUCT INFORMATION | Carrier material | Vials |
| CERTIFICATIONS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid drug / medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes |
| CERTIFICATIONS | ISO:13485 (Latest) Certification for Manufacturing Unit | Yes |
| CERTIFICATIONS | Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes |
| SHELF LIFE | Shelf Life from the date of manufacture (in months) | 24.0 |
| SHELF LIFE | Minimum shelf life of the product at the time of delivery to the consignee | 3/4 th of Total Shelf Life |
| ADVANCE SAMPLE | Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes |
| ADDITIONAL REQUIREMENTS | Additional Requirements | NA |
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Required Documents
1
GST Registration Certificate
2
Permanent Account Number (PAN) Card
3
Experience certificates for similar biological indicators or sterilization products
4
Financial statements (last 2-3 years) or equivalent
5
EMD submission proof (online or DD as specified)
6
Technical bid documents and product specifications
7
OEM authorizations (if applicable) and manufacturing licenses
8
Drug/medical device license under Drugs and Cosmetic Act 1940
9
ISO 13485 certificate for manufacturing unit
10
Batch test reports as per MDR 2017 for supplied products
11
Advance sample submission acknowledgment (upon bid)
Frequently Asked Questions
Key insights about UTTAR PRADESH tender market
How to bid for Ethylene Oxide indicators tender in Varanasi Varun 2026?
Bidders must submit GST, PAN, experience certificates, ISO 13485, MDR test reports, and an EMD of ₹18,000 via GeM. Ensure IS/ISO 11138-1 compliance and provide advance sample for approval before supply. Ensure license under Drugs and Cosmetic Act and batch MDR testing for each lot.
What documents are required for EO sterilization indicators procurement in UP?
Required documents include GST certificate, PAN, company financials, MDR batch test reports, ISO 13485 certificate, valid medical device license, OEM authorizations if any, and proof of EMD submission. Also include technical bid and proof of prior similar supply experience.
What standards must be met for biological indicators in this tender?
Product must meet IS/ISO 11138-1 latest revision, MDR 2017 compliance with batch test reports, and ISO 13485 certification for the manufacturing unit. Ensure drug/medical device license under the Drugs and Cosmetic Act and provide advance sample for approval.
When is the 25% option quantity adjustment allowed for this contract?
Purchaser may increase/decrease quantity by up to 25% at contract award and during currency. Additional delivery time is calculated as (additional quantity/original quantity) × original delivery period, with a minimum of 30 days.
What is the EMD amount and payment terms for this tender?
The EMD amount is ₹18,000. Payment terms follow GeM ATC; ensure submission with bid and comply with any subsequent supplier invoice terms, including delivery and acceptance criteria per tender.
What is required for advance sample submission in this tender?
An advance sample must be provided for buyer approval before commencement of supply. Include documentation detailing sample specifications, conformity to IS/ISO 11138-1, and MDR test results to expedite evaluation.
Which authority licenses are required for medical device products in this tender?
A valid drug/medical device license under Drugs and Cosmetic Act 1940 is required, along with MDR compliance and ISO 13485 certification for the manufacturing unit. Batch test reports must accompany each shipment.
What are the regulatory compliance demands for manufacturing units?
Manufacturers must hold ISO 13485 certification for the facility, MDR 2017 compliance, and maintain MDR batch test reports for every supplied lot. Ensure license validity under the Drugs and Cosmetic Act 1940 and provide documentation at bid or delivery.
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Documents 5
GeM-Bidding-9432784.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS