30mm Bromo Butyl Rubber Stoppers, Sterilized, Bag Of 250
30mm Bromo Butyl Rubber Stoppers, WFI water washed and gamma irradiation sterilization, bag of 250 pcs Round bottom bromobutyl 30mm stoppers The stopper with cleaned, depyrogenated and sterilized, bag of 250 pcs
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Description
PHARMACEUTICAL CLOSURE · STERILISED · RFU
30mm / BROMO / RFU / REAM250
30 mM
Bromobutyl
Rubber Stoppers
WFI washed · Gamma sterilised · RFU · Ream of 250
Sterilised 30 mm bromobutyl rubber stoppers for pharmaceutical vials - WFI water washed and gamma irradiation sterilised, supplied in a ream of 250 pieces, ready-for-use (RFU). Low extractables profile, superior gas permeability resistance, and independent third-party CFU and endotoxin testing. Validated for aseptic pharmaceutical filling applications.
30 mm bromobutyl
Gamma sterilised
WFI washed
RFU
Low extractables
Ream of 250
3rd party tested
30 mm
SIZE
Bromo
BROMOBUYLT
RFU
READY-FOR-USE
3rd Party
CFU + ENDOTOXIN
PRODUCT SPECIFICATIONS
30 mm bromobutyl stopper - complete specification
Pharmaceutical-grade bromobutyl rubber stoppers for large-format injectable vials, lyophilisation containers, and infusion packaging. WFI washed and gamma irradiation sterilised - ready-for-use on your filling line without any additional processing.
Technical specifications
| PRODUCT | 30 mm Bromobutyl Stopper |
| SIZE | 30 mm (Ø outer flange) |
| MATERIAL | Bromobutyl rubber (BIIR) |
| FORMULA CODE | PH701 / equivalent |
| COLOUR | Grey (standard) / custom on request |
| SURFACE TREATMENT | Siliconised (standard) |
| WASHING | WFI (Water for Injection) |
| STERILISATION | Gamma irradiation (≥25 kGy) |
| STERILITY (SAL) | 10⁻⁶ |
| ENDOTOXIN LIMIT | ≤ 0.5 EU/stopper |
| RFU STATUS | Yes - ready-for-use |
| QTY PER REAM | 250 pcs |
| PACKAGING | Double-bag ream (inner + outer PE) |
| 3RD PARTY TESTING | CFU + endotoxin · ISO lab |
| COA | Available with each lot |
| USP COMLIANCE | USP <381> · USP <661> |
| EP COMPLIANCE | EP 3.2.9 · Ph.Eur. 3.1.3 |
Bromobutyl rubber - why it matters
Bromobutyl rubber (BIIR) contains bromine substitution on the isobutylene-isoprene backbone - providing significantly lower gas permeability than standard butyl rubber, superior chemical resistance to pharmaceutical solvents and oxidising agents, and a lower extractables profile. The standard choice for injectable preparations requiring the highest closure integrity.
WFI washed - endotoxin burden control
Stoppers are washed in Water for Injection (WFI, ≤ 0.25 EU/mL) under validated washing conditions. The WFI wash removes particulate matter, chemical residues, and surface bioburden, achieving a clean surface with controlled endotoxin loading before sterilisation - reducing the risk of product contamination during filling and storage.
Gamma irradiation - cold-chain sterility
Gamma irradiation at ≥ 25 kGy achieves a Sterility Assurance Level of 10⁻⁶ without heat exposure. Unlike autoclave, gamma does not require moisture or elevated temperatures - preserving the dimensional geometry and surface properties of the stopper. The irradiated ream is sealed and ready to open directly at your filling line.
Independent 3rd party testing
Each batch undergoes independent testing by an ISO-certified third-party laboratory - separate from our supply chain - for CFU (aerobic colony count / bioburden) and bacterial endotoxin (LAL method, EU/stopper). Test results are provided to approved customers as part of the Certificate of Analysis package. Third-party independence ensures objective, auditable data for your supplier qualification files.
LOW EXTRACTABLES & MATERIAL PERFORMANCE
bromobutyl chemistry - measured, documented, low
the extractables profile of a rubber stopper defines what chemical compounds can migrate from the closure into the drug product. Bromobutyl rubber is chosen specifically for its low and predictable extractables fingerprint - meeting the requirements of USP <1663> and ICH Q3D guidelines
PH701
Standard industry formula code - bromobutyl grey, siliconised, pharmaceutical grade
<5 μg/cm²
Typical non-volatile residue (NVR) per unit area after WFI wash cycle
≤0.5 EU
Endotoxin limit per stopper (LAL method, third-party verified)
Non-Volatile Residue (NVR)
Extractable solids · USP <661>
Bromobutyl rubber exhibits a low non-volatile residue profile - the mass of solid material extractable into 70% isopropyl alcohol or water. For PH701-grade formulations, NVR values are typically well within USP <661> Type I limits. WFI washing further reduces surface-level NVR contribution before the stopper contacts the drug product.
NVR (IPA extract, 70°C): ≤ 5.0 mg/10 cm²
NVR (water extract, 70°C): ≤ 2.0 mg/10 cm²
USP <661> Type I container criteria met
Full extraction study data available on request
Volatile Organic Compounds (VOC)
Headspace GC-MS · ICH Q3D
Bromobutyl rubber contains no plasticisers, no aromatic process oils, and no accelerator systems that generate nitrosamines - key advantages over conventional natural rubber and nitrile formulations. VOC headspace analysis by GC-MS confirms absence of concern-level volatile compounds in pharmaceutical-grade BIIR formulations.
No plasticiser (phthalate) extractables
No nitrosamine-generating cure system
No aromatic process oil extractables
GC-MS headspace data available
Elemental Impurities (ICH Q3D)
ICP-MS · USP <232>/<233>
PH701-grade bromobutyl formulations use pharmaceutical-grade inorganic fillers and are manufactured without heavy metal cure activators. ICP-MS elemental analysis confirms compliance with ICH Q3D / USP <232> limits for elemental impurities in pharmaceutical packaging components - critical for injectable drug product registration submissions.
ICP-MS elemental screening completed
Pb, Cd, As, Hg - below ICH Q3D limits
No heavy metal cure activators in formulation
Elemental impurity data available in DMF
GAS PERMEABILITY PERFORMANCE
Superior barrier to O₂, CO₂, and water vapour
Gas permeability determines how much oxygen, carbon dioxide, and moisture can diffuse through the rubber closure and into the headspace or drug product over time - a critical parameter for oxygen-sensitive formulations, lyophilised products, and long shelf-life injectables.
Gas permeability comparison
Bromobutyl vs common closure materials
Bromobutyl rubber consistently shows the lowest gas transmission rates of any pharmaceutical-grade rubber closure material. The bromine substitution in the polymer backbone creates a denser, more torturous diffusion pathway compared to standard butyl or other synthetic rubbers.
| Material | O₂ permeability (×10⁻¹⁰ cm³·cm/cm²·s·cmHg) |
CO₂ permeability | H₂O vapour |
| Bromobutyl (BIIR) → This product |
0.17 – 0.25 | 0.65 – 0.90 | Very low |
| Butyl (IIR) | 0.21 - 0.35 | 0.90 - 1.20 | low |
| Chlorobutyl (CIIR) | 0.30 - 0.45 | 1.10 -1.50 | low - moderate |
| Natural rubber (NR) | 1.2 - 2.4 | 4.5 - 8.0 | moderate - high |
| Silicone (VMQ) | 55 - 90 | 200 - 350 | very high |
Why low gas permeability matters
Product stability · Shelf life · Regulatory impact
For oxygen-sensitive pharmaceutical products, every microgram of O₂ that permeates through the closure contributes to oxidative degradation - reducing potency, accelerating discolouration, and shortening shelf life. Bromobutyl's low permeability profile directly translates to:
Extended shelf life
Reduced oxygen ingress = slower oxidative degradation = longer product stability at room temperature, reducing cold-chain dependency and waste.
Critical for lyophilised products
Freeze-dried products are extremely moisture-sensitive. Bromobutyl's low water vapour permeability maintains the dry state and residual moisture specification throughout shelf life.
Supports regulatory filing
Permeability data from the stopper supplier is referenced in the Container Closure Integrity (CCI) section of your NDA/MAA/ANDA - demonstrating the suitability of the selected closure for your product.
FORMULATION CODES
Industry formula reference - common codes explained
Pharmaceutical rubber stoppers are manufactured to proprietary compounding formulas identified by industry codes. These codes specify the exact polymer blend, cure system, filler type, and surface treatment - enabling direct comparability between suppliers and simplifying your supplier change documentation.
PH701
Bromobutyl · Grey · Siliconised
The most widely used pharmaceutical-grade bromobutyl stopper formulation. Grey colour achieved with pharmaceutical-grade carbon black. Siliconised surface for low insertion force and good machinability on high-speed filling lines. Low extractables, no nitrosamine-generating accelerators. This product is manufactured to the PH701 equivalent specification.
PH4023
Bromobutyl · Fluoropolymer-coated variant
Fluoropolymer (e.g. Teflon® / PTFE) coated variant of bromobutyl stopper - used where ultra-low extractables and minimal protein adsorption are required. The fluoropolymer film provides a chemically inert product-contact surface with all the mechanical benefits of the bromobutyl substrate underneath. Available on request.
D21-7S
Bromobutyl · Lyophilisation variant
Bromobutyl formulation specifically engineered for lyophilisation (freeze-drying) applications. The vent-slot geometry allows moisture and vapour to escape during the lyo cycle. Stoppering occurs in-chamber under vacuum or nitrogen backfill. D21-7S is a common code used across multiple suppliers for this format; exact dimensional equivalence should be confirmed at order stage.
IGO - 5320
Bromobutyl · Pre-sterilised · Ready-to-use
IGO-5320 (and equivalent codes such as iGo® by West Pharmaceutical, or equivalent RTS/RTF codes from other suppliers) denotes a pre-washed, ready-to-sterilise or ready-to-use supply format. The formulation is standard PH701-equivalent bromobutyl; the code additionally specifies the processing and packaging state, not just the rubber compound.
50 - gray
Standard butyl (reference) - grey
Included for reference: 50-gray denotes a standard grey butyl rubber stopper (not bromobutyl). While widely used and cost-effective, standard butyl has higher gas permeability and a slightly broader extractables profile than bromobutyl. When migrating from 50-gray to a bromobutyl specification, a change notification and extractables comparability study are typically required.
custom
Custom formulation on request
If your filling line, regulatory filing, or drug product compatibility requires a specific formulation code - including fluoropolymer coating, non-siliconised surface, special colour coding, or a specific supplier DMF number - contact us to discuss availability and qualification pathway.
CHEMICAL COMPATIBILITY
Chemical compatibility - bromobutyl rubber
The following table summarises the compatibility of bromobutyl rubber closures with common pharmaceutical excipients, solvents, and drug product vehicles. Compatibility is assessed based on extractables risk, stopper swelling, and chemical interaction at typical product contact conditions. Always validate with your specific formulation.
| Chemical / excipient | Category | Compatibility | Rating | Key notes | |
| Water for Injection (WFI) | Aqueous vehicle | excellent | ★★★★★ | Baseline compatibility; very low extractables into aqueous media | |
| Normal saline (0.9% NaCl) | Aqueous vehicle | Excellent | ★★★★★ | Standard injectable vehicle; no swelling or extractables concern | |
| 5% Dextrose solution | Aqueous vehicle | Excellent | ★★★★★ | Compatible across standard contact times and temperatures | |
| Phosphate-buffered saline (PBS) | Buffer system | Excellent | ★★★★★ | Standard biologic formulation buffer; no compatibility concerns | |
| Citrate buffer (pH 5–7) | Buffer system | very good |
|
Common mAb and protein formulation buffer; generally well tolerated | |
| Histidine buffer | Buffer system | very good |
|
Used in biologic injectables; confirm protein adsorption studies | |
| Polysorbate 20 / 80 (Tween) | Surfactant / stabiliser | good |
|
Common biologic stabiliser; surfactant may slightly increase extractables - monitor at ≥ 0.1% | |
| Polyethylene glycol (PEG 400) | Co-solvent / vehicle | acceptable | ★★★☆☆ | Mild swelling possible at high concentrations; test at target % concentration | |
| Propylene glycol (PG) ≤ 50% | Co-solvent | acceptable | ★★★☆☆ | Some swelling at >30%; validate contact time; low-PG formulations preferred | |
| Ethanol ≤ 10% | Co-solvent | moderate | ★★★☆☆ | Swelling increases with concentration; leachables study recommended; keep < 10% | |
| Ethanol > 30% | Co-solvent (high) | limited | ★★☆☆☆ | Significant swelling and extractables risk; PTFE-coated stopper recommended | |
| Dimethylsulfoxide (DMSO) | Strong solvent | not recommended | ★☆☆☆☆ | DMSO aggressively extracts rubber components; fluoropolymer-lined closure required | |
| Oils (sesame, soybean) | Non-aqueous vehicle | acceptable | ★★★☆☆ | Oil-based formulations acceptable for short contact; verify long-term swelling data | |
| Strong acids (pH < 3) | pH extreme | moderate | ★★★☆☆ | Bromobutyl more acid-resistant than standard butyl; validate at target pH and contact time | |
| Strong oxidising agents (H₂O₂ > 3%) | Oxidiser | limited | ★★☆☆☆ | Oxidative degradation of rubber surface; not suitable for high H₂O₂ product contact | |
| Protein biologics / mAbs | Biologic formulation | good | ★★★★☆ | Good compatibility in aqueous buffer; siliconised surface reduces protein adsorption; confirm with E&L study | |
| Vaccines (aqueous adjuvanted) | Vaccine formulation | good | ★★★★☆ | Bromobutyl widely used in vaccine closure; low interaction with aluminium adjuvants in aqueous base |
★★★★★ Excellent | ★★★★☆ Very good | ★★★☆☆ Acceptable - validate | ★★☆☆☆ Limited - use with caution | ★☆☆☆☆ Not recommended
PACKAGING - REAM OF 250
Double-bag ream - sterile until opened
The 250-piece ream format is designed for pharmaceutical filling operations - a quantity matched to a typical filling batch or filling-line session, with full lot traceability and double-bag sterile integrity.
Outer PE bag - lot labelled
Primary outer packaging · Lot traceability
The outer polyethylene bag carries full lot labelling including product code, lot number, manufacturing date, expiry date, quantity (250 pcs), sterilisation method (gamma irradiation), and product specification. This bag is the primary traceability document that accompanies the ream from our facility to your warehouse and filling suite.
Polyethylene (PE)
Lot labelled
MFG / EXP dates
Product code
Qty verified
Inner gamma-compatible bag - sterile sealed
Secondary sterile barrier · Direct-use bag
The inner bag is manufactured from gamma irradiation-compatible polymer film and contains the 250 stoppers in the sterilised state. The bag is heat-sealed before the gamma irradiation cycle and maintains sterility from the irradiation facility to your filling line. Open the inner bag only within your clean or aseptic environment - the contents are ready to load directly into your filling equipment.
Gamma-compatible film
Heat-sealed sterile
250 pcs inside
Open at filling line
RFU contents
30mm
stopper size
Standard large vial format
BIIR
bromobutyl rubber
PH701-eq · low extractables
WFI + V
processing
WFI washed + gamma sterilised
250
per ream
Double-bag · lot labelled
RFU
ready - for - use
No additional processing
3rd party
ISO-certified lab · CoA per lot
Ready to qualify our stoppers
for your filling line?
Request a Certificate of Analysis,
third-party test data, extractables reports, or a product quote.
We respond within 24 hours.
Custom formulation codes, non-siliconised, and PTFE-coated options available on request.
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