Sterile 20mm Flip Off Caps for Pharmaceutical Vials

Sterile 20mm Flip Off Caps for Pharmaceutical Vials

EO Sterilised
RTU · RFU
Black · Rough matte
Bag of 1,000
No logo · No edge
Pharmaceutical grade

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Description

 PHARMACEUTICAL PACKAGE · STERILE 20mm / BK / 

Black · Rough Matte · No Logo · No Edge · EO Sterilised · Bag of 1,000 · RTU / RFU

 

Sterile
20 mm
Flip Off
Caps

 EO Sterilised · RTU · RFU · 1,000 pcs / sterile bag

Sterile 20 mm pharmaceutical flip off caps - black, rough matte finish, clean edge, no logo, no print. Sterilised by ethylene oxide (EO) to SAL 10⁻⁶. Supplied in a single sealed 1,000-piece sterile bag. Ready-to-use (RTU) and ready-for-use (RFU) - open and apply directly on your filling line. No washing, no autoclave, no re-sterilisation required.

20 mm

Cap size

Black

Rough matte

EO

Sterilised

RTU

Ready-to-use

RFU

Ready-for-use

PROUDUCT NAME sterile 20mm flip off cap
CAP SIZE 20mm
COLOUR black
SURFACE FINISH rough matte
LOGO MARKING none
EDGE DETAIL none-clean edge
CONSTRUCTION Aluminium-plastic combination
STERILISATION METHOD Ethylene oxide (EO)
STERILITY LEVEL SAL 10⁻⁶
QUANTITY PER BAG 1,000 pcs
BAG TYPE Single sealed sterile pouch
RTU / RFU STATUS Yes - no pre-processing needed
PRE-WASH REQUIRED No
VIAL NECK Standard 20 mm crimp
COS / COC Available on request
   

PRODUCT SPECIFICATIONS

 

 Every detail has been specified for pharmaceutical vial filling operations requiring a clean, sterile, traceable closure - delivered in a sealed sterile bag of exactly 1,000 pieces with no additional processing steps required.

 
 

Black. Matte. Sterile.
Ready for your filling line.

01.

Black rough matte - no logo, no edge

The rough matte finish is applied to both the plastic flip off disc and the aluminium skirt. No embossing, no debossed logo, no manufacturer mark - a completely clean, unprinted surface. Ideal for compounding pharmacies, research labs, and CDMOs applying their own labels post-crimping.

02.

EO sterilised - SAL 10⁻⁶

Each bag is sterilised by ethylene oxide (EO) to achieve a Sterility Assurance Level of 10⁻⁶ - the pharmaceutical standard. EO penetrates the sealed bag without heat, preserving dimensional integrity while eliminating all microbial contamination.

03.

1,000 pcs in one sealed sterile bag

Exactly 1,000 caps per bag - counted, sealed, and sterilised as a single lot. One bag = one traceable sterile unit, simplifying batch records, inventory management, and incoming QC in regulated environments.

04.

Standard 20 mm crimp compatibility

Dimensioned to the international standard for 20 mm pharmaceutical vial necks - compatible with all rotary, benchtop, and semi-automatic crimping equipment. Forms a hermetic, tamper-evident seal in a single press cycle.

RTU AND RFU - WHAT IT MEANS FOR YOUR OPERATION

open the bag. crimp. done

no preparatory steps. no additional equipment. no added time on your production schedule

RTU - Ready-to-Use

No pre-processing required

 

No wash cycle. No autoclave. No depyrogenation oven. Open the sealed bag in your clean or aseptic environment and load directly into your crimping system. RTU reduces batch preparation time and eliminates the need for in-house sterilisation equipment.

 

 No washing or rinsing required

 No autoclave cycle needed

 No depyrogenation oven

 Open bag → load crimping equipment → apply

 Reduces preparation time and labour cost per batch

RFU - Ready-for-Use

Validated for regulated production

 

RFU confirms the cap has been manufactured, cleaned, and sterilised to a documented pharmaceutical standard - arriving with the quality attributes required for direct use in GMP pharmaceutical filling and sealing operations.

 

 EO sterilisation to SAL 10⁻⁶

 Sterile bag integrity confirmed before despatch

 Certificate of Sterilisation (CoS) available

 Supports GMP batch record documentation

 Simplifies supplier qualification and incoming QC

ETHYLENE OXIDE STERILISATION PROCESS

Why EO - and what it guarantees

Ethylene oxide is the gold-standard sterilisation method for aluminium-plastic pharmaceutical closures that cannot withstand autoclave or dry-heat processing temperatures.

1

Pre-conditioning

Caps are exposed to controlled humidity and elevated temperature to open the material structure, ensuring EO gas penetration reaches all surfaces of every cap within the sealed bag.

2

EO gas exposure

Ethylene oxide gas penetrates the permeable sterile bag, contacting all cap surfaces. EO alkylates microbial DNA, achieving SAL 10⁻⁶ - less than 1 in 1,000,000 probability of a non-sterile unit.

3

Aeration & degassing

Controlled aeration removes residual EO and by-products to levels compliant with ISO 10993-7 and pharmacopoeial limits - safe for direct pharmaceutical product contact.

4

Sealed sterile bag

The 1,000-piece bag maintains sterility until opened. Each bag carries lot number, sterilisation date, and expiry date for full traceability through your supply chain.

5

Release testing

Sterility and bioburden release documentation confirms cycle performance. Parametric release data available on request, supporting incoming inspection in regulated environments.

6

Certificate of Sterilisation

A CoS or CoC confirming lot number, sterilisation method, SAL, and date is available for every batch - supporting supplier qualification and pharmaceutical batch master file documentation.

 WHO USES THESE CAPS

Built for every pharmaceutical filling environment

 

 

 

Ordered by pharmaceutical professionals who need a clean, pre-sterilised closure without the overhead of in-house washing and sterilisation infrastructure. 

Hospital & compounding pharmacies

 

Aseptic compounding · small batch

Preparing sterile injectable preparations - antibiotics, hormones, oncology - without in-house sterilisation equipment. RTU caps integrate directly into aseptic compounding workflows.

 

Research labs & CROs

 

Clinical trial material · stability

Producing clinical trial material and stability samples. The 1,000-piece bag matches typical research batch sizes - no over-ordering, no waste, full traceability per lot.

 

Biotech startups

 

Pre-clinical · Phase I/II material

Early-stage companies without full sterilisation infrastructure. EO-sterilised RTU/RFU caps enable GMP-compatible production with documentation to support regulatory filings.

 
 

Speciality injectable manufacturers

Peptides · cosmetics · growth factors

Manufacturers filling peptide injectables, cosmetic injectables, and growth factor preparations requiring a premium sterile black matte cap without a manufacturer logo.

 

Veterinary pharmaceutical

Vaccines · injectable preparations

Veterinary vaccine and injectable manufacturers using 20 mm vials benefit from pre-sterilised RTU caps - reducing production steps and improving batch documentation.

 

Contract fill-finish (CMO/CDMO)

Sterile fill · multi-client

CDMOs stocking RTU components for multiple client products. The 1,000-piece bag provides lot-level inventory with sterility documentation for client batch records

 Handling & storage - maintaining sterility integrity

 

Store in the original sealed sterile bag at 15–25 °C, away from UV light and moisture. Do not open until ready for use in a clean or aseptic environment. Check bag integrity on receipt - do not use if the seal is compromised. Once opened, use the full bag contents within the filling session. Shelf life and expiry as indicated on bag label.

 

20 mm

Cap size

Black

Rough matte

EO

Sterilised

1,000

Per sterile bag

RTU

Ready-to-use

RFU

Ready-for-use

Standard pharma vial neck No logo · No edge · No print SAL 10⁻⁶ · CoS available Single sealed pouch per lot No wash · No re-sterilise GMP documentation support

Sterile. Sealed. Shipped.
Ready for your filling line.

 

Order by the bag or by the case. Certificate of Sterilisation available with every lot. Need a different quantity, custom colour, or a CoC for supplier qualification? Contact us - we respond within 24 hours.

 

 

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