Pharmaceutical cleanroom laboratory air filtration South Africa

HEPA Filters for Pharmaceutical Cleanrooms in South Africa

Pharmaceutical cleanrooms need HEPA filters that come with the right documentation — not just a filter that works, but a filter your compliance team can sign off on. Every Airtech H14 HEPA ships with its own serial-numbered test certificate. No chasing paperwork. No batch declarations. The certificate is specific to the unit you install and it is ready for your validation file on delivery. We carry both full-size and half-size HEPA in Pretoria, along with the G4 pre-filters, F9 secondary filters, and F9 V-Bank filters that make up the rest of a typical cleanroom AHU system. One supplier for the full sequence.

Why EN1822 Certification Matters

EN1822 is the international standard used to test and certify HEPA filters. When your QA team or auditor asks for proof that a HEPA filter meets the required performance, the EN1822 test certificate is the document they are looking for.

Our H14 HEPA filters are individually tested — each one gets its own certificate with a serial number. This is different from batch certification, where a sample from a production run is tested and the result is applied to the whole batch. Individual testing means the specific filter installed in your cleanroom has been verified.

The Airtech Filter Range for Pharmaceutical Applications

Pharmaceutical cleanroom air handling typically involves three filtration stages. Each stage has a defined function and a defined certification requirement.

G4 · EN779

Panel Filters

First-stage pre-filtration. Catches coarse dust before it reaches your secondary filters.

View → F9 · EN779

Pocket / Bag Filters

Secondary filtration. The workhorse of the AHU system in cleanroom areas.

View → H14 · EN1822

HEPA Filters

Terminal filtration for your cleanest environments. Individual test certificate included.

View → F9 · EN779

V-Bank Filters

A compact alternative to pocket filters with lower energy consumption. The ABS frame can be incinerated after use — useful where disposal requirements apply.

View →

Why Procurement Chooses Prebur for Pharmaceutical Supply

Individual EN1822 test certificates on delivery. No separate request, no additional lead time. Every H14 unit carries its serial-numbered certificate. Your QA team gets the documentation it needs without chasing the supplier.

Local stock — no import delays for scheduled qualifications. HEPA replacements on a pharmaceutical line are planned events. Import lead times of 8–12 weeks make planning difficult and create risk. Prebur holds stock in Pretoria. Delivery is days, not months.

37 years supplying South African industry. Prebur has supplied filtration to pharmaceutical manufacturers, compounding pharmacies, and hospital procurement teams since 1988. We understand the compliance context and the documentation requirement.

Nick Els — direct contact, not a call centre. Call +27 74 159 1634 or email sales@prebur.co.za. Nick will confirm stock, provide a quote, and advise on any grade or size questions — same day.

Common Questions

What HEPA filter classification is required for GMP Grade A cleanrooms in South Africa? +
GMP Grade A environments require H14 HEPA terminal filtration, certified to EN1822. H14 classification means ≥99.995% overall efficiency at the most penetrating particle size (MPPS) — individually tested, not batch-declared. For MCC GMP compliance and EU GMP equivalence, the filter must carry a serial-numbered EN1822 test certificate per unit. Prebur supplies Airtech H14 HEPA filters with individual test certificates included as standard — the documentation your QA validation file requires.
Do Prebur HEPA filters come with individual test certificates? +
Yes. Every Airtech H14 HEPA filter supplied by Prebur carries a serial-numbered EN1822 test certificate specific to that unit. The certificate confirms overall efficiency ≥99.995% at MPPS and local penetration ≤0.025% at any scan point — the two criteria your validation team will require for IQ/OQ documentation. Certificates are provided with delivery and can be retained in your QA file without any additional request.
What is the lead time for H14 HEPA filters from Prebur? +
Prebur holds Airtech H14 HEPA filters in both full-size (610×610×292mm) and half-size (305×610×292mm) formats in local stock in Silverton, Pretoria. Orders placed before midday are typically despatched same day. For pharmaceutical procurement teams planning a cleanroom qualification or scheduled HEPA replacement, local stock eliminates the 8-to-12 week import lead times that most suppliers in South Africa work with. Call Nick on +27 74 159 1634 to confirm current stock levels.
Which filter grade is required for GMP Grade B and C cleanroom AHU systems? +
GMP Grade B and C HVAC air handling units typically use F9 pocket filters or F9 V-Bank filters as the final supply air filter, with G4 pre-filtration upstream. The F9 stage is rated at ≥95% average efficiency at 0.4µm per EN779:2012 — sufficient for Grade B/C environments and serving as the pre-HEPA filter load protector in Grade A systems. Prebur stocks both F9 pocket filters (595×595×330mm) and the lower-pressure-drop F9 V-Bank format — both rated EN779:2012 with certificates on request.

GMP validation documentation included

EN1822 test certificates per unit · Local stock · +27 74 159 1634

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