Pharmaceutical vials and pill bottles in glass: classification, standards and supplier choice in Belgium

 

For pharmaceutical purchasers, quality managers and category managers, glass is not packaging — it is a regulatory choice. This guide walks through the essential decision points: Ph. Eur. classification (Type I, II, III), hydrolytic resistance and GMP compliance, closure systems, and the documentation that makes your qualification dossier watertight — with particular attention to multi-site harmonisation across Europe.

 

Classification of pharmaceutical glass: Type I, Type II and Type III according to Ph. Eur.

 

Pharmaceutical glass is classified into three types based on hydrolytic resistance, as laid down in the European Pharmacopoeia (Ph. Eur., monograph 3.2.1). This classification is not a formality. It determines which packaging material is legally permitted for which product, and a wrong choice can lead to product recall, validation problems or even patient safety risks.

Type I is borosilicate glass with the highest chemical resistance. It is used for injectables, infusion solutions and strongly acidic or alkaline solutions. Type II is soda-lime glass with a treated (deactivated) inner surface. This type is suitable for aqueous solutions that are not particularly reactive. Type III is untreated soda-lime glass, intended for dry pharmaceutical forms such as capsules, tablets and powders, or for non-aqueous preparations.

This classification has direct consequences for your material specifications, your DMF dossier and your supplier discussions. Category managers working with a centralised purchasing strategy across multiple production sites need to know this three-way distinction down to the level of the test methods, because a supplier delivering Type III as Type II is a compliance risk that only surfaces during audits. And by then it is too late.

The Ph. Eur. also describes the required test procedures: the autoclave test (surface test), the powder test and the granular test. Each type has its own acceptance criteria for hydrolytic resistance, expressed in ml of 0.02 M HCl per gram of glass. Your supplier must provide documentation per delivery demonstrating compliance with these criteria. Ask for it before you fill in a supplier scorecard.

 

The three glass types at a glance

 

• Type I (borosilicate): highest hydrolytic resistance, suitable for injectables and parenterals.
• Type II (deactivated soda-lime): suitable for aqueous solutions with neutral or mild pH.
• Type III (untreated soda-lime): suitable for dry forms, non-aqueous preparations and external applications.
• Test methods per type defined in Ph. Eur. 3.2.1: autoclave test, powder test and granular test.
• Each glass type requires specific CoA documentation per batch.
• Incorrect classification leads to compliance risks during EMA or national authority (FAMHP in Belgium) inspection.
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Glass type	Composition	Inner surface treatment	Typical application	Ph. Eur. test method
Type I	Borosilicate glass	Not required	Injectables, parenterals, biopharmaceuticals	Autoclave test (surface test)
Type II	Soda-lime glass	Deactivated (SO₂ or ammonia treatment)	Aqueous solutions, infusions, eye drops	Autoclave test (surface test)
Type III	Soda-lime glass	None	Tablets, capsules, powders, non-aqueous preparations	Powder test or granular test

The three Ph. Eur. glass types and their specific test methods.

A supplier that does not distinguish between Type II and Type III is not a pharmaceutical supplier — it is a glass trader.

 

➜ Want to know which glass type matches your formulation profile? Request a technical data sheet or contact our pharmaceutical packaging team.

 

Hydrolytic resistance, application table and GMP compliance per glass type

 

Hydrolytic resistance sounds like a laboratory term, but for a purchaser it has a very concrete meaning: it determines whether your packaging keeps the contents chemically intact throughout the entire shelf life. Extractables and leachables — substances that migrate from the glass into the product — are a real risk with poorly chosen glass, and the regulation (EMA guidelines for E&L studies) sets high requirements for their documentation.

Type I glass has a hydrolytic class of HGA1 (surface test) or HGB1 (powder test), representing the lowest ion release. Type III scores HGB3, meaning it can release up to fifty times more alkali than Type I under the same test conditions. For products sensitive to pH shifts or ionic interaction, that is a critical distinction.

From a GMP perspective (EU GMP Annex 1 for sterile products, and the ICH Q6A guideline for specifications), a quality manager expects every purchasing dossier to provide proof of material qualification. That means: a Drug Master File (DMF) or Certificate of Suitability (CEP) from the glass manufacturer, batch test certificates (CoA), and preferably a formal change notification procedure in case the manufacturer makes any modification.

Practice shows that multinationals producing on multiple European sites — Belgium, the Netherlands, Germany, France — need harmonised material specifications. That means: the same glass supplier, the same article codes, the same documentation standard across all sites. A regional distributor capable of European sourcing while simultaneously offering local stock buffers significantly reduces the complexity of that harmonisation.

 

What a quality manager should take away from this

 

• Hydrolytic class HGA1/HGB1 for Type I: lowest ion release in accordance with Ph. Eur.
• HGB3 for Type III: five to fifty times higher alkali release depending on test conditions.
• EU GMP Annex 1 requires material qualification for sterile products.
• E&L studies (extractables & leachables) mandatory for parenteral and inhaler applications.
• CEP or DMF from the glass manufacturer necessary for the registration dossier at EMA or national authorities.
• Harmonised article codes across multiple production sites reduce validation overhead.
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Glass type	Hydrolytic class (surface)	Hydrolytic class (powder)	GMP relevance	E&L risk profile
Type I	HGA1	HGB1	Mandatory for parenterals (Annex 1)	Low
Type II	HGA2	—	Permitted for selected aqueous preparations	Moderate
Type III	—	HGB3	Permitted for dry forms and non-aqueous preparations	Higher in aqueous formulation

Hydrolytic classes per glass type and their GMP positioning.

GMP compliance starts with the material specification — not with the fill.

➜ Need a complete documentation package (CoA, CEP, change notification procedure) for your quality dossier? Contact us — we deliver the technical foundation your QA team needs.

 

Closure systems for pharmaceutical glass: rubber stopper, screw cap and child-resistant closure

 

The vial or pill bottle is one component. The closure is at least as critical, and in practice is too often treated as a secondary concern. A pharmaceutical primary packaging is a system: glass and closure must be validated together when container closure integrity (CCI) is tested in accordance with USP <1207> or ASTM F2338.

For sterile liquids (injectables, infusions), the rubber stopper is the standard. The stopper must comply with Ph. Eur. 3.2.9 (rubbers and elastomers) and the material choice — bromobutyl, chlorobutyl or natural rubber — depends on compatibility with the formula. Bromobutyl rubber is most commonly used for lyophilised applications because of its low moisture permeability. An aluminium crimp cap secures the integrity and is required by most patient safety protocols for parenterals.

For oral pharmaceutical forms — pill bottles, syrup bottles, dropper bottles — screw caps with induction seal or break-disc closures are common. Child-resistant closures (CR for short) are mandatory in the EU for medicinal products falling under Directive 2001/83/EC, unless specifically exempted. The ISO 8317 standard describes the test protocols for CR closures.

Senior purchasers at multinationals prefer not to request this level of detail separately from the glass supplier and the closure supplier. A single point of contact that supplies both the vial and the closure, coordinates compatibility testing and consolidates the documentation saves project time. Gaasch Packaging supplies standard pharmaceutical glass packaging and matching closure systems, and can provide on request technical compatibility documentation aligned with your internal validation processes.

 

The main closure families

 

• Rubber stoppers for sterile injectables: bromobutyl or chlorobutyl in accordance with Ph. Eur. 3.2.9.
• Aluminium crimp cap mandatory for parenteral vials as a tamper-evident barrier.
• Screw cap with induction seal for oral liquids and syrups.
• Child-resistant closure (ISO 8317) mandatory for medicinal products under EU Directive 2001/83/EC.
• Container closure integrity (CCI) testable in accordance with USP <1207> or ASTM F2338.
• Integrated delivery of vial and closure simplifies validation documentation.
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Closure type	Application	Relevant standard	Material	Child-resistant required?
Rubber stopper + aluminium crimp	Injectables, infusions, lyophilised products	Ph. Eur. 3.2.9 / USP <381>	Bromobutyl or chlorobutyl	Not applicable
Screw cap with induction seal	Oral liquids, syrups, drops	ISO 28763 (induction)	PP or PE with film	Yes, if prescription medicine
Child resistant (CR) screw cap	Tablets, capsules, powders	ISO 8317	PP or HDPE	Mandatory under EU 2001/83/EC
Dropper insert + screw cap	Eye drops, oral drops	Ph. Eur. 3.2.9 (at contact)	PE or LDPE insert	Yes, generally mandatory

The four main closures for pharmaceutical glass and their regulatory requirements.

A validated vial with a non-validated closure is not pharmaceutical packaging — it is an open risk.

 

➜ Working with a specific closure system that needs to be validated in combination with your glass vial? Request an integrated product proposal including compatibility documentation.

 

Regulatory documentation, validation and supplier choice for P3 purchasing departments

 

Buying pharmaceutical packaging is not a standard procurement transaction. It is a regulatory decision. And for a P3 purchasing department at a multinational, that means: starting supplier discussions before the RFQ, defining documentation requirements before the request for quotation, and assessing validation risks before the final supplier selection.

The documentation a qualified glass supplier must be able to provide includes at minimum: a Certificate of Analysis per batch (in accordance with Ph. Eur. specifications), a technical data sheet per article, a change notification procedure (formalised in writing), and ideally a Drug Master File or CEP with the relevant European authorities. For products manufactured at multiple European sites, a harmonised specifications database is an additional requirement that not every regional distributor can meet.

Gaasch Packaging has been working with pharmaceutical clients in Belgium, the Netherlands, Luxembourg, France and Germany for more than 100 years. The breadth of that network means in practice that we can source from multiple certified glass manufacturers in Europe, and that we provide a single point of contact for complex harmonisation issues — from initial RFI to delivery on the filling line. As a member of Packaging Alliance Europe, Gaasch has access to a European supplier network capable of handling large-scale multi-site programmes.

For category managers building a supplier shortlist, these are the criteria that count: certification status of the manufacturer (ISO 15378 for pharmaceutical primary packaging is the industry standard), availability of stock buffers that can absorb your production rhythm, MOQ flexibility for tests and new SKUs, and the quality of the documentation that accompanied the first trial delivery. With every candidate supplier, request a trial package — not only the product, but also the complete paper trail. That says more about long-term collaboration than any commercial presentation.

 

What a watertight qualification dossier minimally contains

 

• Certificate of Analysis (CoA) per batch in accordance with Ph. Eur. 3.2.1 as the minimum requirement.
• Change notification procedure formalised in writing before contract signing.
• ISO 15378 as the industry standard for pharmaceutical primary packaging at the manufacturer.
• Drug Master File (DMF) or CEP available for registration dossiers at EMA or national authorities.
• Stock buffers on site or at the distributor to prevent production interruptions.
• Flexible MOQ for new formulation or SKU tests without overinvestment in stock.
• European supplier network for harmonisation across multiple production sites.
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Selection criterion	What to ask the supplier	Gaasch Packaging
Manufacturer certification	Request ISO 15378 certificate from the glass manufacturer	Access to several ISO 15378-certified manufacturers via European network
Regulatory documentation	CoA per batch, CEP or DMF, change notification procedure	Supplied as standard per delivery on request
Stock availability	Lead time and buffer stock during interruptions	Own fleet, on-site stock, flexible delivery planning
Multi-site harmonisation	Can the same article codes be delivered to BE, NL, DE, FR sites?	Yes, via Packaging Alliance Europe
MOQ flexibility	Minimum order quantity for tests and new SKUs	Flexible MOQs available for test phases
Point of contact	One contact person for technology, quality and logistics?	SPOC (single point of contact) model as standard

The six selection criteria for a pharmaceutical glass supplier.

The best supplier is not the one with the lowest price — it is the one whose documentation closes your dossier.

 

➜ Preparing a supplier evaluation for pharmaceutical primary packaging? Gaasch Packaging makes a complete documentation package available for your qualification dossier. Contact us for an initial technical discussion.

 

Ready for a technical conversation?

 

Looking for a reliable supplier of pharmaceutical vials and pill bottles in glass for your production sites in Belgium or elsewhere in Europe? Gaasch Packaging combines more than 100 years of packaging expertise with a European supplier network, flexible stock solutions and complete regulatory documentation. Request a technical conversation or quote today — our team is ready to assess your specific application profile and develop a suitable proposal.

 

Frequently asked questions

 

1. What is the difference between Type I, Type II and Type III pharmaceutical glass according to Ph. Eur.?

Type I (borosilicate glass) has the highest hydrolytic resistance and is mandatory for parenteral applications such as injectables. Type II is soda-lime glass with a deactivated inner surface, suitable for aqueous solutions with low reactivity. Type III is untreated soda-lime glass, suitable exclusively for dry pharmaceutical forms or non-aqueous preparations. The classification is laid down in Ph. Eur. monograph 3.2.1 and co-determines the material choice in your registration dossier.

2. Which documentation should a supplier of pharmaceutical glass vials be able to provide as standard?

A qualified supplier provides at minimum: a Certificate of Analysis (CoA) per batch with the hydrolytic resistance values in accordance with Ph. Eur., a technical product data sheet, a change notification procedure formalised in writing, and preferably a Drug Master File (DMF) or Certificate of Suitability (CEP) with the relevant European authorities. For multi-site programmes, a harmonised specifications database across sites is also an important requirement.

3. Is a child-resistant closure mandatory for all pharmaceutical glass packaging in the EU?

Not for all products. EU Directive 2001/83/EC requires child-resistant closures (in accordance with ISO 8317) for medicinal products considered hazardous to children, unless specifically exempted — for example, for products exclusively intended for elderly users with limited hand function. The assessment of whether a CR closure is required lies with the marketing authorisation holder and is evaluated by the competent national authority (in Belgium: FAMHP).

4. Can Gaasch Packaging supply pharmaceutical glass vials harmonised across multiple European production sites?

Yes. Gaasch Packaging supplies pharmaceutical primary packaging in Belgium, the Netherlands, Luxembourg, France, Germany and the United Kingdom. As a member of Packaging Alliance Europe, Gaasch has a European supplier network that supports the harmonisation of article codes, specifications and documentation standards across multiple production sites. Clients with a SPOC (single point of contact) need for technology, quality and logistics are assigned a fixed project contact.

5. What is ISO 15378 and why is it relevant when choosing a supplier of pharmaceutical packaging?

ISO 15378 is the international standard for the quality management system of manufacturers of primary packaging materials for medicinal products. The standard integrates the GMP requirements of EU GMP Annex 15 into an ISO 9001 structure. For a purchaser or quality manager, ISO 15378 certification of the manufacturer is a baseline requirement in supplier qualification: it proves that the production process, quality control and documentation flow meet pharmaceutical GMP standards. Always request the certificate before final supplier selection.

6. How do I qualify a new glass packaging supplier for pharmaceutical use without delaying my validation cycle?

The fastest route is to qualify in parallel rather than sequentially. Start with a paper qualification (ISO 15378, DMF/CEP, CoA template) before the first physical sample request. In parallel with the quote, request a trial delivery with full documentation, so that you can start CCI testing and E&L screening while the commercial track is running. Where possible, work with an equivalent article reference (equivalency assessment) so that you can build on an existing validation instead of performing a full revalidation. A distributor with its own quality department can prepare the documentation flow upfront and save weeks in your calendar.

7. What is the difference between borosilicate glass and soda-lime glass for pharmaceutical applications and which type do I choose for which product?

Borosilicate glass (Type I) contains boron oxide (B₂O₃), which gives it a low coefficient of thermal expansion and excellent chemical inertness. It is resistant to hydrolysis, acids and bases, and can be sterilised by autoclave or dry heat without loss of quality. That makes it the appropriate choice for parenterals, eye drops and biotechnological products. Soda-lime glass (Type II and III) is cheaper and mechanically more robust for standard applications. Type II, through surface treatment with sulphur dioxide, is suitable for aqueous products with a pH below 7 and for some oral liquid forms. Type III is the standard choice for tablets, capsules and powder preparations. The application table in accordance with Ph. Eur. 3.2.1 is your reference at every product launch.

8. Can Gaasch Packaging assist with technical validation and documentation for pharmaceutical glass packaging, including supplier qualification?

Gaasch Packaging has its own quality and sustainability department that is specifically familiar with the documentation requirements in the pharmaceutical sector. That means you have access as standard to certificates of conformity (CoC), material specifications and traceability information per batch. Gaasch can support you in completing vendor qualification questionnaires and in providing the technical documentation required for your internal approval process and GMP audits. The company is a member of Packaging Alliance Europe, which strengthens access to a broad network of certified manufacturers. For P3 clients with multiple production sites, Gaasch additionally offers the possibility to harmonise the packaging article across locations, with a fixed point of contact (SPOC) as the central interlocutor throughout the entire engagement.

9. Which sustainability requirements apply to pharmaceutical glass packaging under the PPWR regulation?

The PPWR (Packaging and Packaging Waste Regulation) sets minimum requirements for recycled glass content, labelling and reuse that also apply to pharmaceutical primary packaging, although certain exceptions apply to medicinal product packaging due to patient safety and sterility. In practice, this means that pharmaceutical producers must engage with their glass supplier on: the percentage of post-consumer recycled glass compatible with Ph. Eur. requirements (often a tension point for Type I), labelling requirements on secondary and tertiary packaging, and the impact on DMF dossiers in the event of a change in glass composition. Explicitly ask your supplier for a PPWR roadmap per glass type and involve your QA team early in any material change.

10. How do I evaluate pharmaceutical glass packaging suppliers based on volume capacity, EU certifications and harmonisation across multiple production facilities?

For P3 purchasers at multinationals, three criteria are decisive: volume capacity and supply security (including back-up sources and safety stock arrangements), EU certifications and technical compliance (ISO 15378, GMP Annex 15, Ph. Eur. compliance), and harmonisation capability across multiple production or filling sites in Europe. Evaluate suppliers on their ability to deliver a uniform article across different locations, with consistent batch properties and centralised documentation. A distributor with a European network and its own quality department can be a strategic buffer between the glass manufacturer and your filling line, particularly when supplier diversification is part of your supply chain risk management. Also include responsiveness to RFIs/RFQs in your scorecards as a criterion: it is an early indicator of operational maturity.